When Carlos L. Arteaga, MD, reflects on the people who have influenced his career and his contributions to the prevention and cure of breast cancer, his first thoughts go not to his physician father or any of his notable mentors. 

Instead, he thinks first about the patients who have volunteered as research participants, making it possible for him and others to uncover treatments that will benefit subsequent generations. 

“I thank these patients for their courage, their example, and the shining light they provide, because it illuminates the research we do and the application of it,” said Arteaga, who since September 2017 has served as director of the Simmons Comprehensive Cancer Center and associate dean of oncology programs at the University of Texas Southwestern (UTSW) Medical Center in Austin.

Arteaga played a crucial role in identifying what roles insulin-like growth factor receptors and transforming growth factor-β in breast cancer progression and in exploring how they might be targeted for treatment. He contributed to the development of a treatment for HER2-mutated cancer that combines chemotherapy with trastuzumab (Herceptin), a monoclonal antibody that stops cancer cells from growing and dividing. Forty years ago, HER2-mutated breast cancer was among the deadliest cancers. Now it’s one of the most curable.

Further, Arteaga was one of the first researchers to report on cellular alterations that confer resistance to therapies targeted to the ERBB family of receptors, including HER2, which is known to be amplified in approximately 20% of all breast cancers. He also was among the first investigators to observe that loss of tumor suppressor PTEN confers resistance to ERBB receptor–targeted therapies, and his work identified the role of aberrant PI3K signaling and HER2-activating mutations on resistance to estrogen receptor-targeting therapies. 

“We always try to understand the ‘why,’ ” he said. “[If] we find a smoking gun, we want to know how the smoking gun does it.” 

Arteaga, past president of the American Association of Cancer Research, the world’s largest cancer research organization, noted the incredible improvements in cancer outcomes between the 1980s, when he began his postgraduate training, and today. 

“In the 2000s, the idea that breast cancer was generally a lethal disease was flushed down the toilet,” he said. “It became very clear that there were major improvement in patient outcomes as a result of research, clinical trials, and early mammography screening.” 

Looking ahead, Arteaga predicts that as more people live longer and with cancer being a disease associated with aging, we may see more cancers in future years, However, with early detection and continuous advances in therapy, the overwhelming majority of these are likely to be caught early and be cured.

“Today, even patients with advanced cancer can have a long life,” he said. “Some cancers will continue to be a serious problem, like brain, ovarian, [and] pancreas cancers—they’ll still be very challenging. But in terms of the big ones—lung, colon, breast, prostate—we’re going to see more, but that doesn’t mean they’re going to be incurable.”

Arteaga grew up in the port city of Guayaquil, Ecuador, the oldest of 4 children. His mother was a homemaker. His father was a physician and professor who eventually became a dean at Universidad de Guayaquil’s medical school. Both parents made sure their children realized they were privileged in a country where not everyone’s basic needs—shelter, food, education, health—were being met. They encouraged their children to do more: Study another language, consider life in other countries, help others, understand “that it was OK to just open our wings and go,” Arteaga said.

Medicine was basically the family business, Arteaga said. Two of his great-uncles had also been physicians and his father maintained offices in the family home and at the university. “My father brainwashed me into becoming a doctor, starting in elementary school,” Arteaga joked. “I thought it was a cool thing to do.”

After college, he wanted to study medicine in the United States, but it was cost prohibitive, even for the son of a university administrator and practicing pulmonologist. Instead, Arteaga attended the medical school in Guayaquil, where his father was dean. There, he often served as a simultaneous translator for visiting American physicians, including Joseph E. Murray, MD. Murray won the Nobel Prize in Physiology or Medicine for performing the world’s first successful transplant of an organ from one living person to another at Boston’s Peter Bent Brigham Hospital in 1954. 

“He was royalty at Harvard,” Arteaga remembered. Thanks to Murray’s help, Arteaga did 2 long stints as a visiting student at Peter Bent Brigham Hospital, experiences that further convinced him he needed to study in the United States. 

After a stretch in Boston, Arteaga stopped in Atlanta, Georgia, before returning to Ecuador, to visit a friend who was studying at Emory University School of Medicine. Arteaga spent a month in Atlanta, primarily at Grady Memorial Hospital. “They let me hang around,” he said. “They saw me in action, and they said, ‘If you apply here, we’ll give you a spot in the residency.’”

Arteaga graduated from Facultad de Ciencias Médicas in Guayaquil in 1981, then became just the second graduate of a foreign medical school accepted into Emory’s internship and residency programs. He initially pursued cardiology, but that changed when, as a third-year resident, an inspiring attending physician took him on rounds into the oncology ward. 

Arteaga was struck by the attending physician’s empathy as well as his clinical and scientific knowledge. And he was taken by the bravery and strength of the patients who endured so much without knowing if their treatment would be successful.

“I saw the early cures. I saw the promise,” Arteaga said. “We knew so little about cancer back then. I realized I would be able to ask interesting and challenging research questions.” 

Arteaga completed his work at Emory, then moved west for a fellowship in medical oncology and hematology at The University of Texas Health Science Center at San Antonio. There he worked closely with C. Kent Osborne, MD, and the late, legendary William L. McGuire, MD, who coined the term “breast cancer translational research” and who discovered the use of the estrogen receptor as a biomarker in breast cancer.

With Osborne, Arteaga learned the endocrinology and role of growth factors in breast cancer. He also considered McGuire a key mentor. “Anything you saw him do, you wanted to emulate. He always aimed for perfection in [conducting and presenting] research. He always planned ahead. He was also extremely competitive. All of those things I remember of him and they also shaped me.”

San Antonio, Arteaga says, “was just a great place to work. We were young physician/scientists doing trials with some senior people already well known in the field,” including Osborne, who would later become the founding director of the Dan L. Duncan Comprehensive Cancer Center at the Baylor College of Medicine. “It was just magical for someone with a budding career in translational research.”

Arteaga’s passion for research thrived at in Texas. “I worked my butt off. I wrote and published a bunch of papers. I got an early grant for a young investigator award. I knew what I wanted to do,” he said. 

When he was wrapping up his time in Texas and looking for another job, McGuire told Arteaga to let him first contact the leadership at any institution that seemed interesting to him. He believes McGuire’s influence and support played a role in him getting a job as assistant professor of medicine at Vanderbilt University in 1989 in Nashville, Tennessee.“

My letter, they would have thrown in the trash, but not his letter,” Arteaga said. “I’ve done the same for people I’ve trained.”

At Vanderbilt, Arteaga focused on translational research. By 1996, he was leading the breast cancer program at Vanderbilt-Ingram Cancer Center. Although research was his primary focus, Arteaga continued to see patients during his time in Nashville.

“The work I do is not basic science. It’s translational research, in between basic discovery and standard clinical care. It’s important to understand the needs of patients, the trends in clinical care, that leading edge, the horizons,” he said. “Having that patient contact is a constant reminder of those needs so we can shape the work we do in the laboratory.”

Arteaga spent 28 years at Vanderbilt. He served in several positions, including director of the Center for Cancer Targeted Therapies, director of the breast cancer program, and associate director of translational and clinical research at the Vanderbilt-Ingram Cancer Center.

“Our group was one of the first to test drugs in patients directly to understand how they worked in short presurgical (aka window) trials where we’d use a drug before a patient has a mastectomy or lumpectomy, then score the cellular and molecular effect on the operated cancer to try to understand how it works, [and if we used] the right dose,” he said. “We did this in a way that is deliberate and safe, that has the buy-in of the patient even though the information generated might not be helpful to her but to other patients with the disease.”

In 2017, Arteaga got an unexpected job offer: Would he be willing to move to Texas to join UTSW? He hadn’t been looking to leave Nashville, but the more he learned about the opportunities in Texas, the more he realized he needed to take the job.

“I didn’t leave Vanderbilt. I came here. There’s a difference,” he said. “This was just a great opportunity here in Texas that I found difficult to pass up, where I felt I could have a larger impact than I’d had at Vanderbilt. Like Vanderbilt, UT Southwestern also has a [National Cancer Institute]–designated center and my job was to continue that mission in a larger city with greater access, a diverse and generous community, and a legislature that had already allotted billions for cancer science through the Cancer and Prevention Research Institute in Texas (CPRIT).”

Despite his large administrative and institutional and national service duties, he still makes time for research. Arteaga considers his role at UTSW as “the advocate-in-chief of cancer science,” noting that “every day here is very full and rewarding.” In addition to his role at UTSW, Arteaga cochairs the annual San Antonio Breast Cancer Symposium; serves on the advisory boards of nonprofits, including Stand Up to Cancer and Susan G. Komen, and at least 8 NCI-designated Cancer Center External Advisory Boards; sits on multiple award committees; and provides editing and insight to multiple scientific publications.

“I’m on a list of people whose opinion, for some reason, is considered of value, and I do believe it’s part of academic citizenship to always offer our opinion and experience and work with others,” he said. “We also learn from others.”

Articles

For the past 3 decades, Carlos L. Arteaga, MD, has focused his research on drug-resistant breast cancers, seeking to identify the causes of resistance and proposing combination therapies to beat that resistance.

Understanding the Smoking Gun 

At the very start of his medical career more than 40 years ago, when most oncologists only hoped to turn cancer into a chronic disease, Michael B. Atkins, MD, had a different goal: He was looking for a cure.

A tall order for sure, and a seemingly insurmountable one when the cancer in question was melanoma. “The cancer that gives cancer a bad name,” as Atkins called it. Melanoma affected people young and old, spread rapidly and widely, and at that time, killed 90% of patients with metastatic disease within 2 years. 

“Few oncologists wanted to take care of it,” said Atkins, who has served as deputy director of the Georgetown Lombardi Comprehensive Cancer Center since 2012. “So many lives lost, motherless children, fatherless families, really a lot of tragedy, and few wanted to be involved with it.”

Atkins believed immunotherapy would make all the difference. His earliest research involved recombinant human interleukin-2 (IL-2) and lymphokine-activated killer cells. Atkins’ “eureka” moment came when a 28-year-old man with metastatic melanoma treated with the protocol returned weeks later for a checkup. His neck was swollen with a goiter and blood work showed he’d developed hypothyroidism. But his tumors were gone. 

“That suggested to me that the treatment was working by stimulating immunity against the tumors,” Atkins recalled. Although this type of response was relatively rare, occurring in only 10% of patients, it served as proof of principle that the immune system, if properly activated, could eliminate the last cancer cell, producing a cure.

Atkins said his experience with IL-2 proved that cytokine-based immunotherapy could be curative. Investigators spent the next 20 years trying to develop regimens that either improved the cure rate or reduced the toxicity—and, failing in those regards—later trying to identify those who would benefit the most from immunotherapy. This led to the observation that some patients had immune cells that recognized the tumor cell but could not kill those tumor cells because of unknown factors in the tumor microenvironment. 

The breakthrough came from the work of James P. Allison, PhD, the 2014 Giants of Cancer Care® award winner for Scientific Advances, and Tasuku Honjo, MD, PhD, who shared the 2018 Nobel Prize in Medicine for discovering that immune “checkpoint” proteins prevented tumor-specific T cells from being fully activated. Those inhibitory checkpoints, CTLA-4 and PD-1, put the brakes on the immune response. The development and application of antibodies against those checkpoints—pembrolizumab (Keytruda), nivolumab (Opdivo), and ipilimumab (Yervoy)— unleashed the immune system to kill tumor cells. 

Atkins and colleagues at Yale University, Memorial Sloan Kettering Cancer Center, and the University of Pittsburgh wanted to see how dual checkpoint blockade with antibodies against both PD-1 and CTLA-4 would affect melanoma progression. The nivolumab/ipilimumab combination induced extended treatment-free melanoma remissions in more than 50% of patients. Today, it is the standard of care for not just melanoma, but also for patients with kidney cancer, non–small cell lung cancer, mesothelioma, and other diseases.

“Immunotherapy has turned my melanoma clinic from a place of fear and suffering to a veritable travel agency, as patients are finishing their treatments and returning to their precancer lives,” said Atkins, also the Scholl Chair in Medical Oncology at Georgetown University Medical Center. “They’ve been given a second chance at life, and they’re pursuing it with gusto.”

Atkins is modest about his own contributions, but his clinical and translational research efforts in melanoma and kidney cancers and immune, anti-angiogenic, and targeted therapies have uncovered critical biology of these diseases that have led to more than 20 FDA-approved treatments. Still, he wants to do more. 

“I would say being a giant in melanoma may seem like being a big fish in a small pond, but the impact we’ve had on oncology in general has been enormous,” said Atkins, who’s still excited to go to work after all these years. “I truly believe we are in the midst of nothing short of a revolution in cancer therapy. Progress in immunotherapy is not just changing the way we care for patients with many cancers, but the very way we think about cancer.”

Atkins grew up in Milwaukee’s North Shore suburbs, the third of 5 children. His twin brother, Edward, claimed the second spot, arriving in the world 13 minutes earlier. Edward also became a doctor, focusing on anesthesiology. He retired about 2 decades ago.

“My parents always thought of me as being the less-successful one since I’m still working,” Atkins explained.

His father, Julius, a Navy veteran, completed law school and then worked in real estate development. Atkins’ mother, Mildred, was one of the first women to earn an engineering degree from the University of Wisconsin. Her November 2020 obituary noted that she and her husband shared with their children “their belief that hard work, passion, and commitment made any goal achievable.”

Atkins describes a happy childhood, living next to a man-made lake with friends nearby, winters spent ice skating, and summers filled with water sports. At one point, he considered becoming a professional water skier. 

“I figured I wasn’t going to make it, but I still love being out on the water,” he said.

He chose to attend Tufts University in Medford, Massachusetts, as an undergrad, making him an outlier in a family thick with degrees from the University of Wisconsin. He wasn’t sure of his academic or career paths, but something his father said before dropping him off at the airport for his first flight to Boston stuck with him. 

“He said, ‘You know, if I had to do it over again, I might have been a doctor instead of a lawyer,’ ” Atkins recalled. “I always loved science and I loved interacting with people—and being a doctor has been a way to do both.”

Tufts didn’t have a waterskiing team, so Atkins joined the Jumbos swim team. Being a college athlete taught him a lot about time management and teamwork.

“It has been very important to me to have functioning teams...where everybody gets recognized for their contributions and has an opportunity to lead specific efforts rather than one person getting all the glory.”

Atkins met Susan Crockin the first day of freshman orientation, and they quickly became a couple. As college graduation loomed, both knew they wanted to attend postsecondary schools, him for medicine and her for law, but the big question was where? Atkins’ parents wanted him to join his brother at the University of Wisconsin School of Medicine and Public Health. Crockin’s parents wanted her to move closer to their Virginia home.

Their solution? Tufts University School of Medicine for him, making him a “double Jumbo,” and Northeastern University School of Law for her. “We decided to stay in Boston,” Atkins said. “Then we stayed 40 years.”

Atkins was immediately drawn to oncology. He’d enjoyed cell biology classes as an undergraduate, and “cancer was really just applied cell biology.”“I wanted to be in a field with patients who really cared about their disease, who would come to their appointments and do what you asked them to do. You weren’t just a nuisance; these were serious health issues that they cared deeply about, and you were responsible for managing them,” he said. “I also wanted to be in a field that was a challenge, where most of the problems hadn’t been solved and there was a lot of room for advances. I wanted to be continually challenged throughout my career. Oncology met all of those criteria.”

Atkins became interested in immunotherapy while a medical student. He began working on immune-based cancer treatments for patients before he’d even done his oncology fellowship. He was inspired by the work being done by John M. Kirkwood, MD, at the University of Pittsburgh and Steven A. Rosenberg, MD, PhD, now at the National Cancer Institute (NCI). Both men are now Giants of Cancer Care®.

James W. Mier, MD, a recently retired associate professor of Harvard Medical School, was one of Atkins’ earliest mentors and later a close colleague.

"It’s important for someone who is a clinician interested in doing translational research to have a laboratory partner to bounce ideas off, to provide preliminary data for clinical trials, write grants with, and do the correlative studies for translational research,” Atkins said. “Jim Mier was that for me for 30-plus years.”

The first 2 decades of Atkins’ career were buoyed by research grants, allowing him to divide his time between the lab and the clinic. The losses outweighed the successes, making each win all the sweeter. And that 28-year-old patient with metastatic melanoma who was part of Atkins’ eureka moment? He’s now in his 60s.

“He was newly married and had no children when we treated him. Now he’s a grandfather. It shows you the impact of potentially curative therapy,” Atkins said. “When things were really bleak, when we were helping less than 10% of patients, we’d do things like count their offspring to remind ourselves we were making a difference.”

Atkins spent almost his entire adult life in Boston. He and Susan raised 3 children there while he worked at Tufts Medical Center and then Beth Israel Deaconess Medical Center (BIDMC) and played a leading role in multiple collaborative research projects. He led the Cytokine Working Group from 1992 to 2008, co-led the first NCI Melanoma Specialized Programs of Research Excellence (SPORE) grant, led the Dana-Farber/Harvard Cancer Center Kidney Cancer Program and the first Kidney Cancer SPORE grant, and founded and co-led the Melanoma Research Foundation Breakthrough Consortium. 

He also established and led the BIDMC Cancer Center’s cutaneous and biologic therapy programs, was president of the Society for Immunotherapy of Cancer, codeveloped a new staging system for melanoma, served as coeditor of the Cutaneous Melanoma textbook, and continues to edit the melanoma chapters for 

In 2012, Atkins made a major career and life change, moving to Washington, DC, to become deputy director of Georgetown Lombardi Comprehensive Cancer Center.

Atkins has continued his melanoma, kidney cancer, and immunotherapy research. He began work on dual checkpoint blockade and now leads the DREAMseq trial (NCT02224781), comparing the sequence of targeted therapy followed by dual checkpoint blockade versus the reverse sequence in patients with metastatic BRAF-mutant melanoma. 

He’s also looking at the combination in patients with brain metastases, exploring developing biomarkers for response and toxicity with the regimen and when it is safe to stop treatment.

Most recently, Atkins joined the NCI’s Investigational Drug Steering Committee Immunotherapy Task Force.

“I’m looking at ways to be helpful, focusing on novel aspects like identifying biomarkers for response and safely stopping treatments and trying to figure out the prerequisites for successful combination regimens that will improve outcomes while maintaining the curative potential of immunotherapy,” Atkins said.

While preparing to leave Boston, Atkins compiled a list of 22 “Atkins’ Aphorisms” to remind himself of the important lessons he’d learned over time. They can also serve as guidelines for younger physicians. Among his lessons:

The secret to good patient care is caring about the patient. Put yourself in their shoes, and try to make recommendations you would be comfortable receiving.

Clap for others. People like applause. Support your staff, and look for opportunities to support their careers. You will benefit in the reflected light of their accomplishments.

You need to work for people you respect and who respect you. Your bosses should want to help you succeed, not just protect their own status.

Atkins has proven that he lives these words, particularly the one about how good patient care starts with caring for the patient. When Atkins was officially named the Dr Scholl Chair in Medical Oncology at Georgetown in 2017, Lombardi Comprehensive Cancer Center Director Louis M. Weiner, MD, shared his favorite story about Atkins, whom he’d met at Tufts when he was a fellow and Atkins was a resident.

Weiner said that Atkins was vacationing in Florida when he bumped into a former patient. Years earlier, he had treated the man for melanoma with one of the first immunotherapy drugs. 

Atkins’ treatment had cured the man, and he wanted to introduce the doctor to his son. The boy was born after the man finished therapy. “This is the impact that greatness has on our society,” Weiner said. “This is the impact of great and innovative work.”

When Atkins addressed the crowd upon receiving the Dr Scholl Chair, he introduced former patients as “not just cancer survivors but thrivers.” He pledged to keep looking for a cure for today’s patients and future patients. 

“I don’t intend to rest on any laurels as there is still much more to be done,” he promised.

“I don’t intend to rest on any laurels as thereis still much more to be done.”

 A Leader in the Revolution: Michael B. Atkins Is Giant of Cancer Care in Melanoma

As CEO of the American Society of Clinical Oncology (ASCO), Clifford A. Hudis, MD, is always on the go—and not just between his home in New York and ASCO headquarters in Virginia. 

With his team, he constantly searches for ways to support ASCO’s more than 45,000 members and their practices, ensuring that all patients receive the quality cancer care they deserve, working with elected and appointed officials on public health initiatives, and developing continuing education programs and workshops to keep cancer doctors around the world at the top of their game. 

But at least once a month, Hudis will spend a Friday afternoon at Memorial Sloan Kettering (MSK) Cancer Center in New York, New York, where he served as chief of the Division of Breast Cancer Medicine for 18 years. There he meets new patients and manages the care of existing ones, satisfying his desire to be a physician and keeping himself up to date on the evolving challenges doctors face. 

“Over the years, I’ve been in rooms where people are discussing and deciding profound policy issues related to clinical care, sometimes they had not, themselves, touched a patient in years or even decades. Given the privilege of representing ASCO’s diverse membership, I always want to retain at least some connection to real-world clinical care,” Hudis said. “Not only is it emotionally and professionally rewarding to sit and talk with patients, but it is also useful for my role at ASCO. I always want to relate to our members as a peer, sharing some of the same day-to-day challenges and representing their needs accurately.” 

Hudis took the helm at ASCO in 2016 after more than 30 years as a practicing physician. He had spent most of those years at MSK, first as a fellow, then as a collaborative clinical and translational researcher focused on drug development. This included developing the practical dose-dense adjuvant chemotherapy regimens for breast cancer. 

He rose to the rank of attending physician and full member at MSK while becoming a professor of medicine at Weill Cornell Medicine. There’s a big difference between the clinical work and research that marked the bulk of his career and managing what is functionally a large, nonprofit corporation with multiple connected entities and international reach. Yet Hudis believes a background in medicine can be great preparation for leadership and administration, be it at a business or a nonprofit. AS CEO, he’s asked to make decisions every day that affect thousands of ASCO staff and members. 

“This is where practicing medicine is a useful training ground,” he added. “I do think my clinical experience gives me some comfort with decision-making in the face of imperfect information.” 

Hudis grew up in a middle-class neighborhood in Northeast Philadelphia, Pennsylvania. His mother was a public school teacher, and his father built and owned a food distribution business. From a very young age, Hudis remembers, his parents nudged him toward a career in medicine and encouraged his interest in science and math. 

Hudis considered specializing in psychiatry until he started his oncology rotation in a clinic run by MCP professors Rosaline R. Joseph, MD, and Emmanuel C. Besa, MD. “The combination of cutting-edge technologies, a reliance on the scientific method, and the strong bond that developed between doctors and their patients greatly appealed to me,” Hudis said. 

After medical school, applying for a fellowship at MSK was a no-brainer for Hudis. As a boy, he’d seen the 1971 movie Brian’s Song, which is based on the true story of Chicago Bears running back Brian Piccolo and his battle with an aggressive form of germ cell testicular cancer. Piccolo, who was just 26 when he died in 1970, sought treatment at MSK. 

“When I applied to medical oncology fellowships, it was my first choice, and I think that seed was planted by Brian Piccolo’s story,” he said. 

At MSK, Hudis was one of the first fellows to work with the legendary Larry Norton, MD, as Norton developed the center’s breast cancer program. Hudis found a lifelong friend and mentor in Norton, who today serves as senior vice president, medical director at the Evelyn H. Lauder Breast Center, and the Norna S. Sarofim Chair in Clinical Oncology at MSK. Norton, and won a Giants of Cancer Care® award in 2016. 

“What that really meant was that all of the academics, the science, the learning, the hard work and study can only make us experts up to a certain point. The life and experience of individuals with cancer is another most critical form of expertise,” Hudis said. “They know the impact the disease has on their lives. They know what they want to achieve with treatment. That’s always stuck with me.” 

Hudis said 2 “accidents of history” helped further his career. The first was the early development of filgrastim (Neupogen), a recombinant, nonpegylated human granulocyte colony-stimulating factor analogue that stimulates the growth of white blood cells. MSK helped develop curative breast cancer regimens that incorporated filgrastim. 

The second big break also involved a treatment drug, paclitaxel. When the FDA approved the cytotoxic agent in 1992, paclitaxel was the first new conventional chemotherapy introduced in decades found to have broad use and clinical efficacy. Hudis and his colleagues further developed paclitaxel-based chemotherapy into a standard postoperative adjuvant treatment regimen. 

“When I started in the oncology clinic at MCP, I could list all of the known effective drugs for the treatment of cancer and, in short form, it would fill only 2 sides of 1 page,” Hudis said. “The subsequent expansion of effective options, which is only growing faster today, is really exciting and is exactly what I hoped to see during my career.” 

When ASCO’s CEO position became available in 2016, Hudis had been exploring the links between obesity and breast and other cancers with colleagues at MSK and Weill Cornell Medicine for about 10 years. That research convinced him that public policy and awareness would have to be part of any solutions. ASCO offered the possibility of effective intervention on a global scale. 

Hudis steered ASCO as it launched some of its boldest initiatives to date, including CancerLinQ, the only physician-led big data platform in the country. He worked with other research and medical institutions to boost federal support for cancer research, which was stalled for almost a decade. 

“I recognized that science was important but so, too, was evidence-based public policy,” he said. “And to engage political leaders in Washington, you have to be there; ideally, backed by strong data.”

As CEO of the American Society of Clinical Oncology, Clifford A. Hudis, MD, is always on the go—and not just between his home in New York and ASCO headquarters in Virginia. 

Making a Difference Face to Face and Across the Globe With Cancer Policy Efforts

Limited financial and medical resources available to cancer treatment centers in developing nations often make it difficult for physicians there to follow best practices widely adopted in the United States and other highly affluent countries. The National Comprehensive Cancer Network (NCCN) is working to change that by developing modified guidelines for specific regions that offer less-costly and less—technologically intensive alternatives.

In developing these sets of Harmonized Guidelines, the NCCN has recognized the growing international use of its core set of guidelines on treating multiple cancer types. These were downloaded globally more than 10 million times in 2018, although not as frequently in less-developed countries. Overall usage is rising—downloads in 2018 were up 26% from 2017. Modified guidelines from the NCCN have already been developed for sub-Saharan countries and the Caribbean (

“We recognize that just having the guidelines on the web isn’t sufficient. They were initially developed for those with high resources at US comprehensive cancer centers. They need to meet the needs of patients and care providers at different locations where medical resources vary,” said Wui-Jin Koh, MD, the NCCN’s senior vice president and chief medical officer.

“We’re working on translations and with experts from around the world to adapt and harmonize the guidelines for [physicians’] specific regions, to give them novel ways of implementing guidelines-concordant care tailored to resource availability and to provide a platform for advocacy of improving care delivery systems with their governments,” he said.

NCCN care recommendations, determined by multidisciplinary panels from 28 leading academic cancer centers, cover about 97% of all cancers. They include recommendations for treatment of cancer by site and provide information on prevention and risk reduction and supportive care. There are also guidelines tailored to specific populations and patient educational products.

In addition to the Harmonized Guidelines already established in sub-Saharan Africa and the Caribbean, a related harmonization effort called the Middle East and North Africa (MENA) NCCN Adaptation Project was concluded in January. The NCCN also plans to update the Harmonized Guidelines to keep up with changes in the NCCN’s core guidelines.

The core guidelines are constantly refreshed. In 2018, for example, the NCCN’s “parent” breast cancer guidelines were updated 4 times and its non—small cell lung cancer (NSCLC) guidelines got 6 updates. Its Harmonized Guidelines are based on the parent guidelines but are modified to reflect the general standard of care (SOC) in specific regions of the world. In addition, less-sophisticated care options are provided for physicians who may not be able to provide regional SOC.

The NCCN is now working closely with experts in Latin America, the Pacific Basin, and Spain. In late April, for example, NCCN representatives met with health leaders in Bolivia to begin crafting guidelines that could be optimized for varying resources. The first 3 adaptations will focus on breast, cervical, and rectal cancers based on the highest incidences and greatest need for the region.

“We want to take advantage of every opportunity we have to advance the standard and accessibility of care globally,” said NCCN Chief Executive Officer (CEO) Robert Carlson, MD. “We have a process we’ve used in multiple settings, going through the guidelines page by page, decision by decision, to see what’s possible and what’s not for a specific setting. And if something’s not possible, we look at what pragmatic and evidencesupported alternatives can be used instead. Sometimes doctors don’t have access to a certain cancer drug, so we might have to find the next most successful drug.”

All versions of the NCCN Harmonized Guidelines come with 3 levels of recommendations: Black text indicates generally available SOC for that locale; gray text refers to care that may be costly, technically challenging, and/or have a lesser impact on oncologic outcome; and blue text provides regional options to consider when best practices aren’t available.

A Look at NCCN Harmonized Guidelines in Sub-Saharan Africa

Life expectancy in sub-Saharan Africa is rising partly due to better control of infectious diseases like HIV, malaria, and cholera. Cancer rates, however, are also increasing due to the longer life expectancy. The incidence of cancer is expected to double by 2040 to 1.6 million cases per year.

 In this region, more than 50% of patients with cancer die within a year of diagnosis, as most patients—about 80%&mdash;seek care only when the disease is advanced, according to Abubakar M. Bello, MD.

Further complicating the situation is that few people have insurance and drug costs are high. Certain oncologic drugs may not be available. Residents also have limited access to cancer care centers, although that is improving. Not long ago, Bello, of the National Hospital in Abuja, Nigeria, was the sole oncologist serving about 16 million people. His slim cancer-fighting arsenal included an occasionally faulty 17-year-old linear accelerator.

Without “the privilege of specialization,” Bello said, he was expected to know how to diagnose and treat multiple cancers, “and you tend to be a bit confused if you don’t have something to fall back on.”

Bello and the NCCN worked with the African Cancer Coalition and Nigerian Health Minister Isaac Adewole, MBBS, an oncologist, on the creation of guidelines for sub-Saharan Africa that focused on how to achieve the best results with limited resources and provide a pathway for further development of cancer care systems.

They first determined which cancers were among the most prevalent in their area. In Nigeria’s case, this included breast, cervical, and prostate cancers. They then determined what treatments were available. There are now 19 NCCN Harmonized Guidelines for sub-Saharan Africa. The governments of Ethiopia, Nigeria, and Tanzania have formally endorsed the guidelines.

One example of sub-Saharan Africa— specific guideline harmonization is the treatment of cervical cancer. Pelvic external beam radiation therapy and brachytherapy are the NCCN’s primary recommendations for locally advanced cancer. But in recognition of limited resources in the area, the guidelines suggest the alternative of neoadjuvant chemotherapy followed by radical hysterectomy if there is no access to radiotherapy.

Another example can be found in breast cancer. A chest CT with contrast is the NCCN’s primary, or “black text,” recommendation for systemic staging, but because such technology may not be readily available, the guidelines in blue suggest using a pragmatic alternative of chest x-ray with abdominal ultrasound.

“It’s a bit early, but we do know this is a step in the right direction. There’s a lot of enthusiasm to follow the guidelines, and practices are changing because of the guidelines,” Bello said. “Patients are properly staged before starting treatment because doctors are downloading the guidelines and trying to follow them.

“In a few years, maybe 5, we hope to have cancer centers that are NCCN-accredited so we can use all of that expertise to lower the death rates of patients in sub-Saharan Africa,” Bello said. “We’re getting cancer care, and it’s becoming more affordable, and it’s almost on par with developing nations, even if it’s not [on par with] the United States.”

NCCN Harmonized Guidelines for the Caribbean

Marisa Nimrod, MD, chair and CEO of the Caribbean Association of Oncology and Hematology (CAOH), said adaptation and implementation of the NCCN guidelines will be a regional goal this year. There are currently 7 NCCN Harmonized Guidelines for the Caribbean.

“The Caribbean Harmonized Guidelines present a more hand-in-glove fit for the resources available within this area,” said Owen Gabriel, MD, a consultant oncologist at Victoria Hospital in Saint Lucia and chair of an NSCLC guideline initiative. “Although there is no formal adoption, these guidelines are being promoted via their use as the backbone of multidisciplinary tumor boards as well as individualized patient care.”

Still, the changes were not extensive, according to Gilian Wharfe, MD, clinical chair of the NCCN CAOH guideline development initiative. “Most of the changes made were related to lacking certain technology [and] skilled surgeons and, most of all, the unavailability/affordability of the medications used in the treatment of these conditions,” she said. “The cost of medication has a huge impact on how we treat our patients.”

One example of how the guidelines have been harmonized for the Caribbean is a recommendation for neoadjuvant platinum- based chemotherapy in advanced cervical cancer if initiation of SOC chemoradiation must be delayed.

Figure. Sample of NCCN Harmonized Guidelines for Sub-Saharan Africa: Version 2.2017, Breast Cancer

“The NCCN Caribbean Harmonized Guidelines afforded the evidence and justification for this option, which is not typical for the more advanced stages of disease,” Gabriel said. “The results have been astounding, with generally no difference in outcome when compared with patients who underwent the [SOC] option.”

 In Jamaica, Sophia Edwards-Bennett, MD, chair of the NCCN/CAOH guideline harmonization initiative, said the guidelines were modified to “reflect the current technologies available in Jamaica at this juncture.” Thus, clinical practice generally aligns with the new construct. “Although not empirically determined, the gap between aspiration and reality has been largely addressed,” she said.

Physicians in Jamaica are preparing to distribute the guidelines electronically and via pamphlets, a process that will be complemented by medical conferences.

Edwards-Bennett echoed Wharfe’s comment about the high cost of anticancer drugs in Jamaica, noting that “this challenge is not only applicable to novel targeted therapies, such as immunotherapy, but [includes] conventional regimens as well.”

Abdul-Rahman Jazieh, MD, MPH, chairman of the MENA NCCN Adaptation Project, said doctors in this region turn to the NCCN guidelines because they cover most common cancer and clinical scenarios, are continuously undated to incorporate recent evidence, and are easy to access and understand. Harmonization, he said, required minimal changes, “as our aim is to practice medicine similar to US oncologists. We kept changes at a high level as resource-stratified guidelines give choices to oncologists to choose adaptation at different levels.”

One example of a MENA-adapted guideline is for the treatment of NSCLC. Lung cancer has the highest incidence among cancers in 7 of 13 Arab countries, and data indicate that NSCLC is on the rise.

Primary NCCN guidelines recommend molecular testing for metastatic NSCLC. The MENA adaptation recommends establishing an independent molecular tumor board (MTB) or including experts in thoracic MTB meetings to carefully assess the need for, and results from, molecular testing.

Primary NCCN guidelines also recommend either completing or interrupting systemic therapy in patients who are found to have molecular biomarkers, such as 

rearrangements, during first-line chemotherapy. The MENA adaptation clarifies that chemotherapy should be interrupted in the event of serious adverse events and appropriate tyrosine kinase inhibitor therapy should be initiated.

The rollout of the adapted guidelines has encouraged many cancer care centers in the region to enhance their practices, Jazieh said. “They accelerated the adoption of the latest treatment options, especially when it comes to precision medicine, including workup and management,” he said. “We use the NCCN guidelines to convince hospital leaders to have access to medications on formulary” or that are not on formulary but are part of the NCCN guidelines.

National Comprehensive Cancer Network Harmonized Guidelines for sub-Saharan Africa: breast cancer, version 2.217. NCCN website. Updated November 3, 2017. Accessed May 1, 2019. www.nccn.org/ professionals/physician_gls/pdf/breast_harmonized-africa.pdf.

Dent J, Manner CK, Milner D, et al. Africa’s emerging cancer crisis: a call to action. BIO Ventures for Global Health website. bvgh.org/ wp-content/uploads/2017/07/Africas-Emerging-Cancer-Crisis-ACall- to-Action.pdf. Published June 2017. Accessed May 1, 2019.

Salim EI, Jazieh AR, Moore MA. Lung cancer incidence in the Arab League countries: risk factors and control. 

. 2011;12(1):17- 34. researchgate.net/publication/51074223_Lung_Cancer_Incidence_ in_the_Arab_League_Countries_Risk_Factors_and_Control.

The NCCN is working to develop modified guidelines for specific regions that offer less-costly and less–technologically intensive cancer treatment alternatives.

NCCN Goes Global With Guidelines Tailored for Treatment Capabilities Abroad

When the FDA approved its first biosimilar drug in 2015

—filgrastim-sndz (Zarxio), for compromised white blood cell count&mdash;there was talk of the benefits of competition in the pharma industry; increased access to medications for patients; and, of course, the all-around savings. After all, the cost of developing and guiding a biosimilar through the approval process is a fraction of the cost of developing a reference biologic: in the range of $100 million to $250 million versus $2.6 billion for a new prescription medicine.

Four years later, those benefits haven’t been fully realized, according to Gary Lyman, MD, MPH, senior lead of health care quality and policy at the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center in Seattle, Washington. “There is some evidence of price reduction, but it’s too early to tell if biosimilars will fulfill expectations,” he said. “As people become more comfortable with biosimilars and we see multiple agents competing with originators, we hope we see meaningful price reductions. We’re not going to see 80%, like generics, but even 10% to 15% reductions, at the national level, would represent billions of dollars in potential savings.”

Biosimilars are complex molecule agents that bear almost identical resemblance to original biologics that have lost their patent exclusivity. Just 3 years out of the starting gate, biosimilars in the United States are too hazy a target for precise savings analysis. The Rand Corporation has been studying this emerging market since before Sandoz’s filgrastim-sndz became the first biosimilar challenger on the American scene. Rand estimated potential biosimilar savings of $44.2 billion over the 2014-2024 period (range, $13 billion-$66 billion), or 4% of total biologic spending.

 In a 2017 update, the estimate was just marginally higher, although adjusted downward for degree of market penetration: $54 billion (range, $24 billion-$150 billion) over the 10-year period ending in 2026, or about 3% of estimated total biologic spending.

 Other estimates put the potential 10-year savings as high as $250 billion.

These estimates, in fact, are significantly more optimistic than what has been achieved in the European Union (EU), where biosimilars were first introduced in 2006 and those approved by the European Medicines Agency (EMA) numbered 54 by the start of 2019.

 A report by IMARC indicated sales of biosimilars in the EU reached just US$2.9 billion in 2018 and projected a total of US$11.7 billion by 2024.

 Biosimilars are taking hold in other regions of the globe, such as Korea, where a significant manufacturing industry dedicated to biosimilars has sprung up, and India, where more than 25 biosimilars have been approved for marketing.

Observers cite multiple reasons for the slow uptake stateside: There are a limited number of biosimilars on the market—18 have been approved thus far, including oncologic agents and supportive medications (

 In addition, manufacturers of originator products, upon which biosimilars are based, have been accused of blocking the market entry of these competitor products and discouraging public acceptance of them. Further, some providers hesitate to change a patient’s treatment plan if costly reference biologic drugs are working, for fear the biosimilars won’t be as successful.

“I’m a practicing oncologist, and some of us have used [originator biologics] for 10, 15, 20 years, and we’ve gotten very comfortable with them,” Lyman said. Given the very nature of biologics— the complex manufacturing involved and the difficulty of preparing identical batches of drugs&mdash; it is doubtful that parallelism of quality between biosimilars and biologics can be maintained over the long haul, Lyman said: “I would argue that all biologics are prone to drift with changes in conditions, and studies have shown original biologics on the shelf today are not the same as they were 15 years ago. The originator drugs we’ve gotten really comfortable with are really biosimilars to the ones we started using years ago.”

Biologics have led to breakthroughs in oncology and other serious diseases, and they typically cost tens of thousands of dollars for a year of treatment, and with this amount of money at stake, manufacturers of original biologics are suspected of deliberately trying to thwart the introduction of lower-cost biologics, according to a news report earlier this year. Outgoing FDA Commissioner Scott Gottlieb, MD was quoted expressing concerns about “deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of biosimilars, which the FDA examines for reliability and efficacy as part of marketing approval.

 Gottlieb in July announced that the FDA had created a Biosimilars Action Plan as part of its mandate to encourage innovation and spur price-lowering competition in the drug market. The report indicated that generic drugs, facilitated by the Hatch-Waxman Act of 1984, for instance, now represent 90% of all prescriptions in the United States and generated $265 billion in savings in 2017 alone.

 It was only recently that the FDA launched a statutory pathway to approve follow-on versions of biological products, which amount to 40% of all prescription drug spending and 70% of the growth in drug spending from 2010 to 2015.

In tandem with the action plan announcement, Gottlieb was “worried that the market for these products still isn’t established,” he explained. “The ability for these products to penetrate clinical practice and gain acceptance is still not firm. That doesn’t mean that the future doesn’t hold a lot of promise for biosimilars. It just means that the future is uncertain.”

Biosimilars are one way to address the increasing cost of prescription medicine. In November 2018, Pfizer began offering the anemia treatment drug epoetin alfa-epbx (Retacrit), a biosimilar to epoetin alfa (Epogen/Procrit; Amgen), at the wholesale acquisition price of $11.03 per 1000 U/mL. That’s 57% lower than Procrit ($25.72 per 1000 U/mL) and 33% lower than Epogen ($16.58 per 1000 U/ mL). In July 2018, Pfizer received FDA approval for neutropenia biosimilar filgrastim-aafi (Nivestym), the company’s second oncology supportive care biosimilar.

 Pfizer also has 4 other drug candidates in mid-to late-stage development for the treatment of cancer or as supportive care.

The steep discount connected with the launch of epoetin alfa-epbx helps fulfill expectations and hopes that the entry of biosimilars in the US market will challenge current pricing levels and improve access to medications, although there are no guarantees that prices even for biosimilars will not be scaled up along with the general march of drug cost inflation. “By introducing [epoetin alfa-epbx ] in the US market at a significant discount to its reference products, Pfizer is offering immediate savings to the healthcare system in hopes that patients and their physicians will have access to additional high-quality treatment options,” said Thomas Biegi, director of Global Media Relations at Pfizer, adding that the company couldn’t predict future pricing for epoetin alfa-epbx or other new biosimilars. “Each molecule has specific drivers that determine market price, including number of competitive entrants, so we expect pricing to naturally evolve differently for each biosimilar.”

Studies show that biosimilar competition has driven down overall prices in Europe. For example, epoetin biosimilars have contributed to price declines per treatment day averaging 31% across a wide selection of EU countries, according to a recent report.

 However, epoetin sales in the EU have been adversely affected by a warning that for patients with cancer, the preferred method of correcting anemia should be blood transfusion. There are other examples of the success of biosimilars abroad. In the United Kingdom, use of granulocyte colony-stimulating factor biosimilars eventually surpassed the originator drug in market share.

But that success didn’t happen overnight. Similar to how the FDA is working to encourage biosimilar adoption, the EMA in essence put its thumb on the scale when, in 2009, it updated clinical guidelines to encourage the use of biosimilar versions of filgrastim.

 That led to a significant increase in use, with a larger number of patients selecting the lower-cost drugs in earlier stages of their therapy. The EMA continues work to promote biosimilars: In September 2018, EMA and the European Commission published an animated video available in 8 languages for patients that explains what biosimilars are and how the EMA works to ensure they are as safe and effective as their reference drugs. At the same time, it released a guide to biosimilars for healthcare professionals in 7 languages after previously publishing it just in English.

Similar efforts would make a difference in the United States, too, said Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina and vice president of the Community Oncology, Alliance (COA). Patel is leading COA’s new biosimilars committee, an initiative aimed at providing high quality, accessible, and affordable cancer care.

“One reason we decided to create this committee is to identify the barriers facing biosimilars,” Patel said. “Not very many physicians are familiar with what they are or what the FDA process is. We feel that COA has the resources, plans, and, perhaps, obligations to work with the different stakeholders to reduce hurdles and to help facilities understand how biosimilars can reduce overall cost without affecting outcomes.”

According to Biegi of Pfizer, the company maintains that “uptake and utilization of biosimilars in the United States will be dependent upon multiple factors, including trust on the part of physicians and patients that the biosimilar will perform as well as the reference product.”

“Uptake of biosimilars typically begins in new patients, and as experience builds, existing patients are considered,” Biegi said. “Pfizer’s position is that all switching decisions regarding biosimilars should be made by the treating physician, on an individual patient basis, supported by scientific evidence, and with full patient awareness. It’s crucial that we continue to educate physicians and patients to create confidence and—to be honest&mdash;[and to correct] wrong information that is spread, causing fear and doubt of biosimilars among patient and provider groups.”

That’s a sentiment echoed by Molly Billstein Leber, PharmD, manager of medication policy and formulary management at Yale New Haven System in Connecticut. She adds that “solid basic and clinical science will serve as the backbone of biosimilar acceptance.”

 Billstein Leber has noted that lawsuits filed by originator companies have kept would-be biosimilars locked up in the starting gate. A recent lawsuit filed against Johnson & Johnson and Janssen by Walgreens and Kroger alleges that the biopharmaceutical companies engaged in anticompetitive practices to stop payers from covering biosimilars of infliximab.

However, Billstein Leber acknowledges that based on the slow uptake of generics, it’s understandable that biosimilars in the United States are still sitting on the launchpad despite their moonshot potential in terms of savings and improved access for patients. “I am not surprised by the current biosimilar situation and overall adoption rates, especially when you look at our previous experiences with generic medications. It took 30 years after the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984 for 89% of prescriptions now to be filled with generic medications,” she said. “Even today, many provider MDs still prefer using the branded/originator product for therapies with a narrow therapeutic range. This acceptance took a significant amount of work and was driven by the need to mitigate prescription drug expenses.”

Education, Billstein Leber concluded in her research, is “the key driver of biosimilar acceptance.” She cites the results derived from a 2016 survey of more than 1200 US physicians across specialties who are high subscribers of biologics.

 Among the most striking findings: 20.5% of responders incorrectly said a pharmacist could substitute a biosimilar without prescriber permission, 43.8% of physicians were not aware that biosimilars must be comparable in safety and efficacy to the originator biologic, 35.9% believed that biosimilars were less safe than the originator biologic, and 38.9% were interested in learning more about the FDA approval process for biosimilars.

Similarly, patients also lack information about biosimilars, Billstein Leber said. She believes an agency on the federal level should be responsible for baseline education. The FDA, individual doctors and practices, and medical associations also need to promote it. There is a noticeable lack of educational materials available, and Billstein Leber thinks that COA’s new committee could fill that gap. Education will lead to more biosimilar usage and more savings, she said. “The more often we see [biosimilars], the more comfortable everyone will be. We all need to share our successes and what barriers we have overcome in our journey for biosimilar adoption.”

Sullivan T. FDA approves Sandoz’s Zarxio, the first biosimilar approved in the U.S. Policy & Medicine. Updated May 5, 2018. policymed.com/2015/03/fda-approves-sandozs-zarxio-the-first-biosimilar-approved-in-the-us.html. Accessed February 25, 2019.

Sullivan T. A tough road: cost to develop one new drug is $2.6 billion; approval rate for drugs entering clinical development is less than 12%. Policy & Medicine. Updated May 6, 2018. policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html. Accessed February 25, 2019.

Blackstone EA, Fuhr JP. The economics of biosimilars. 

. 2013;6(8):469-478. ncbi.nlm.nih.gov/pmc/articles/PMC4031732/.

Mulcahy AW, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. Rand Corporation website. rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Published 2014. Accessed February 25, 2019.

Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States. 

. 2018;7(4):3. ncbi.nlm.nih.gov/pmc/articles/PMC6075809/. Published March 30, 2018. Accessed February 25, 2019.

Miller S. The $250 billion potential of biosimilars. Express Scripts website. lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars. Published April 23, 2013. Accessed February 24, 2019.

Biosimilars approved in Europe. GaBI online website. gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Updated December 14, 2018. Accessed February 25, 2019.

Biosimilar market in Europe: industry trends, share, size, growth, opportunity and forecast 2019-2024. IMARC website. imarcgroup.com/europe-biosimilar-market. Published February 2019. Accessed February 25, 2019.

Biosimilars development moving to Asia. GaBI online website. gabionline.net/Reports/Biosimilars-development-moving-to-Asia. Published June 29, 2018. Accessed February 25, 2019.

Biosimilar product information. FDA website. www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580432.htm. Updated January 18, 2019. Accessed February 25, 2019.

Rowland C. ‘Marketers are having a field day’: patients stuck in corporate fight against generic drugs. Washington Post. January 9, 2019. washingtonpost.com/business/economy/drugmakers-alleged-scare-tactics-may-hold-back-competition/2019/01/09/612ac994-046d-11e9-9122-82e98f91ee6f_story.html?noredirect=on&utm_term=.3419a44cd2f2. Accessed February 22, 2019.

Biosimilars action plan: balancing innovation and competition. FDA website. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf. Published July 2018. Accessed February 25, 2019.

Cultivating a vibrant U.S. market for biosimilars: a conversation with FDA’s Scott Gottlieb. Brookings website. brookings.edu/events/u-s-market-for-biosimilars-fda-scott-gottlieb/. Published July 18, 2018. Accessed February 25, 2019.

U.S. FDA approves Pfizer’s biosimilar Nivestym (filgrastim-aafi) [press release]. New York, NY: Pfizer Inc; July 20, 2018. pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_biosimilar_nivestym_filgrastim_aafi-0. Accessed February 25, 2019.

IQVIA. The impact of biosimilar competition in Europe. google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwi_jNHLqNfgAhUrmeAKHZykCCEQFjAAegQICBAC&url=https%3A%2F%2Fec.europa.eu%2Fdocsroom%2Fdocuments%2F31642%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fnative&usg=AOvVaw29beGo7y5l0rDapUeBqsuL. Published September 2018. Accessed February 25, 2019.

Billstein Leber M. Optimizing use and addressing challenges to uptake of biosimilars. Am J Manag Care. 2018;24:-S0. ajmc.com/journals/supplement/2018/managing-costs-advancements-biosimilars/optimizing-use-and-addressing-challenges-to-uptake-of-biosimilars. Published November 19, 2019. Accessed February 25, 2019.

Patel KB, Arantes Jr LH, Tang WY, Fung S. The role of biosimilars in value-based oncology care. 2018;2018(10):4591-4602. doi: 10.2147/CMAR.S164201.

Improving understanding of biosimilars in the EU [press release]. Canary Warf, London, UK: European Medicines Agency; September 13, 2018. ema.europa.eu/en/news/improving-understanding-biosimilars-eu. Accessed February 25, 2019.

DiGrande S. Walgreen, Kroger file antitrust suit against J&J, Janssen over Remicade. The Center for Biosimilars website. centerforbiosimilars.com/news/walgreens-kroger-file-antitrust-suit-against-jj-janssen-over-remicade. Published June 11, 2018. Accessed September 6, 2018.

Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. 

. 2017;33(12):2160-2172. doi: 10.1007/s12325-016-0431-5.

When the FDA approved its first biosimilar drug in 2015&mdash;filgrastim-sndz, for compromised white blood cell count&mdash;there was talk of the benefits of competition in the pharma industry; increased access to medications for patients; and, of course, the all-around savings. Four years later, those benefits haven’t been fully realized,

Natalie Pompilio

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