Biosimilars

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.

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).

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,

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.

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

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.

The first FDA-approved biosimilar, Zarxio, is now available for patients in the United States, following a series of lawsuits and court decisions.

An appellate court ruled that the FDA-approved biosimilar Zarxio can be marketed in the United States after September 2, 2015.

The FDA's approval in March of the first biosimilar drug for the US market has aroused much concern among physicians.

The first FDA-approved biosimilar, Zarxio, has been blocked from reaching US markets by an injunction from Amgen, the manufacturer of the G-CSF analog counterpart, Neupogen (filgrastim).

The FDA has approved its first biosimilar, Zarxio, for all five its counterpart Neupogen's authorized indications.

2015 has certainly got off to an exciting start in oncology!

In a 14-0 vote, the FDA's ODAC unanimously recommended approval of EP2006, a biosimilar version of filgrastim. If the FDA follows the recommendation, the drug would become the first biosimilar approved in the United States.