Biosimilars

Biocon has announced that the FDA has issued a complete response letter for Mylan’s biologics License Application for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim (Neulasta).

The FDA approved the first biosimilar for the treatment of cancer. ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients.

The FDA has accepted a biologics license application for the rituximab biosimilar Rixathon, according to Sandoz, the company developing the treatment.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.