Biosimilars Poised to Have Global Impact on Oncology

Sunil Verma, MD

As costs continue to trend upward in oncology, a comprehensive plan must be established so that patients with cancer can continue to receive systemic therapy, said Sunil Verma, MD.

While the implementation of biosimilars would likely assist in reducing cancer treatment costs, Verma added that there are other important factors to consider. For example, researchers need a better benchmark for what is said to be “clinically meaningful” in order to focus on the cost-effective treatment options with the greatest benefit.

“We need to set up structures to assess things like overall response and other important data so we can ultimately provide the best possible treatment,” said Verma, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre.

Several biosimilars have been approved by the FDA, including the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) for use in patients with HER2-positive breast cancer, in addition to HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.

Phase III data from the HERITAGE trial presented at the 2018 ASCO Annual Meeting indicated clear equivalence for MYL-1401O compared with standard trastuzumab. MYL-1401O in combination with taxane-based chemotherapy for frontline treatment of patients with HER2-positive breast cancer mirrored the progression-free survival rate of patients treated in the same setting with trastuzumab.

OncLive: What impact would the implementation of biosimilars have?

In an interview with OncLive^®, Verma shared insight on the benefits and unanswered questions that remain with biosimilars in oncology.Verma: There are a couple aspects to look at when we talk about global impact. One would be the cost of care. The second would be the integration of these new agents. In terms of cost of care, introducing biosimilars would reduce the burden of cost that's becoming an issue all over the world. This is especially true for biologic agents in cancer. The numbers [for biosimilar costs] are quite durable between what we've seen in North America and what we see across to Europe. Depending on what kind of cost reductions we get, this would have a significant impact.

Why might there still be skepticism regarding biosimilars?

Do drug manufacturers pose a challenge in terms of implementing a more cost-driven solution?

If the cost of treatment continues to rise, is the field of oncology sustainable without biosimilars?

The secondary impact would be our ability to then shift these walls and integrate these new therapies so people can have access to them. We have to look at it in a way that allows any patient with cancer to have the option of a number of new, innovative treatments. If this comes to be, and we see an improvement in patient outcomes, that would be great for oncology. We're hoping this will be the case.Mainly, the skepticism is that it remains to be seen what the cost reduction would look like. It is [unknown] how we are going to be able to collect real-world evidence to measure the integration of biosimilars. This has not been fully assessed yet. Also, there is skepticism because biosimilars would essentially replace therapies that have been providing significant clinical value to our patients. Any time you introduce a change, there's always this healthy doubt. Patients and oncologists want to be absolutely sure something works before they use it. Therefore, we need to make sure we're implementing new agents that are doing what they're labeled to do—and that is reducing cost and providing similar clinical benefit.It's hard to know. There will certainly be a competitive threat any time you want to introduce a new biosimilar. It is hard to say what this could mean for the drug companies, especially if a biosimilar could devalue one of their brands. In the clinical realm, we need to be supportive of methods that will lead to cost reduction. We need to have innovation in mind as the most important thing. Would biosimilars lead to greater innovation? That's something we still have to decide. One dogma might be that biosimilars would be stemming innovation just because they're driving down costs. I would argue that it would create greater innovation if we can divert some of those dollars to other newer therapies.It's a very provocative question. I would like to think that the field of oncology has a bright road ahead. The interest and investment that exists both from the industry, researchers, patients, and academia will lead to better therapy. The only way we can sustain and accelerate this is to address cost. Biosimilars would be one element, but it's not the only element. It's part of the approach.

Do you see any potential for biosimilars to be used in combination?

Looking specifically at breast cancer, which is where you specialize, there are a number of trastuzumab biosimilars being introduced. How could this shape the breast cancer paradigm?

In addition to biosimilars, we also need to look at more precision therapies. We need to set effective benchmarks for what we consider to be clinically meaningful; this way, we're only using therapies that provide the best outcomes. We need to set up structures to assess things like overall response and other important data, so that we can ultimately provide the best possible treatment. These different discussions need to be considered along with the implementation of biosimilars. Also, we need to provide better direction in terms of how we can justify the cost of drugs. We need to give our clinical perspective there.It's a very important point to think that the role of biosimilars should not just be limited to single-agent treatment. The role of biosimilars should also be extended to combination-based strategy so we can rationally offer this treatment to a greater population. The biosimilar industry needs to also support programs including combination strategy, patient education, and patient activism. This all provides value to our relationship with patients.It's nice to have this sort of competition between agents, and it's good to have different companies providing these biosimilars. One of the things we need to factor when we're in a situation like this is the production. Do these companies providing biosimilars have the proper infrastructure to develop the right pipeline? We obviously look to our regulatory agencies to provide guidance and support for this, but also to the manufacturers themselves to make sure they're doing their part. This allows us to decide the right partner moving forward.