Biosimilars | Specialty

FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O

August 30th 2017

The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.

ODAC Votes to Recommend Approval for Trastuzumab Biosimilar MYL-1401O

July 14th 2017

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to recommend approval to MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals.

ODAC Unanimously Supports Bevacizumab Biosimilar ABP-215

July 13th 2017

The FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval for ABP-215, a biosimilar for bevacizumab (Avastin) to treat a range of solid tumors.

FDA Issues Complete Response Letter for Epoetin Alfa Biosimilar

June 23rd 2017

The FDA has rejected Hospira's a biologics license application for the epoetin alfa biosimilar, epoetin hospira, citing manufacturing concerns at the company's fill-finish facility in McPherson, Kansas.

Biosimilar Rituximab Approved in Europe for Non-Hodgkin Lymphoma

June 20th 2017

The European Commission has approved the rituximab (Rituxan) biosimilar Rixathon (GP2013) to treat patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

ODAC Recommends Approval of Epoetin Alfa Biosimilar

May 25th 2017

The FDA’s Oncologic Drugs Committee voted 14-1 to recommend approving a biologics license application for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira.

Oncology Pipeline Bursting With Biosimilars

May 3rd 2017

After years of regulatory and legal wrangling, the development of biosimilars is starting to advance rapidly in the United States, particularly in the oncology sector where multiple versions of the most widely used cancer drugs are moving forward.

FDA Approval Sought for Bevacizumab Biosimilar

November 16th 2016

A biologics license application (BLA) has been submitted for ABP-215, a biosimilar version of bevacizumab (Avastin), based on data from analytical, pharmacokinetic, clinical data, pharmacology, and toxicology data, according to a statement from Amgen and Allergan, the developers of the biosimilar.

Dr. Hope Rugo on Safety of Trastuzumab Biosimilar for HER2+ Breast Cancer

October 14th 2016

Hope Rugo, MD, a professor of Medicine and director of the Breast Oncology Clinical Trials Program at the UCSF Helen Diller Family Comprehensive Cancer Center, discusses MYL-1401O, a proposed biosimilar for trastuzumab (Herceptin), in patients with HER2-positive metastatic breast cancer.

Dr. Esteva on Clinical Trial Design of Trastuzumab Biosimilar in HER2+ Breast Cancer

September 7th 2016

Francisco J. Esteva, MD, PhD, medical oncologist, New York Langone Medical Center, discusses the importance of having a clinical trial of the trastuzumab (Herceptin) biosimilar MYL-1401O for patients with HER2-positive breast cancer.

Dr. Hope Rugo on Trastuzumab Biosimilar in HER2-Positive Breast Cancer

August 24th 2016

Lead Investigator Emphasizes Impact of Equivalent Efficacy With Trastuzumab Biosimilar in HER2+ Breast Cancer

August 19th 2016

Hope S. Rugo, MD, discusses the recent findings with MYL-1401O and the role of biosimilars in patients with HER2-positive breast cancer.

Dr. Dang on the Significance of the MYL-1401O Biosimilar in HER2-Positive Metastatic Breast Cancer

July 26th 2016

Chau Dang, MD, medical oncologist, chief, West Harrison Medical Oncology Service, Memorial Sloan Kettering Cancer Center, discusses the significance of MYL-1401O, a proposed biosimilar of trastuzumab, as a potential treatment for patients with HER2-positive metastatic breast cancer.

Trastuzumab Biosimilar Passes Phase III Test for HER2+ Breast Cancer

July 21st 2016

The biosimilar ABP 980 demonstrated similar pathologic complete response rates as the reference product trastuzumab (Herceptin) in a phase III study for patients with HER2-positive early breast cancer.

Dr. Esteva on Trastuzumab Biosimilar in Patients With HER2+ Breast Cancer

July 7th 2016

Francisco J. Esteva, MD, PhD, medical oncology, New York Langone Medical Center, discusses a phase III study of the biosimilar version of trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer.

Biosimilar Era Gets Rolling in Oncology

June 17th 2016

After years of anticipation, biosimilar versions of the most widely administered monoclonal antibodies in oncology care are moving closer to fruition for the US market, starting with a new form of trastuzumab (Herceptin).

Patient Longevity Will Be Key Driver in Hematology Market Growth

June 12th 2016

Incoming generic and biosimilar substitutes for dominant, brandname hematology drugs may lead to less costly treatment, but a lot will depend on the quality and supply of these new products,

Biosimilar Trastuzumab Matches Herceptin in Efficacy and Safety

June 4th 2016

A biosimilar version of trastuzumab demonstrated equivalent efficacy and safety to the FDA-approved branded drug in a randomized phase III study among patients with HER2-positive metastatic breast cancer.

NCCN Readies Practitioners for Tapping the Potential of Biosimilars

April 1st 2016

While biosimilars have the potential to create competition and result in healthcare savings, the path to the marketplace has proven complex.

Dr. Zelenetz on the Role of Biosimilars in Cancer Care

March 31st 2016

Andrew D. Zelenetz, MD, PhD, medical director, Quality Informatics, Memorial Sloan Kettering Cancer Center, discusses the role of biosimilars in cancer care. Zelenetz spoke about this topic at the 2016 NCCN Annual Conference.