FDA to Review Bevacizumab Biosimilar, While Roche Hopes to Defend Its Patent

Last week, Amgen and Allergan announced that the FDA will review data supporting the firms’ Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.

The FDA Advisory Committee will review the analytical, pharmacokinetic, and clinical data from studies on ABP 215, including the results of a phase 3 study that met its primary endpoint of demonstrating clinical equivalence to the reference product in patients undergoing treatment for non-squamous, non-small cell lung cancer. The study also demonstrated comparable safety and immunogenicity profiles for ABP 215 and the reference bevacizumab.

While Amgen and Allergan have said that they believe their product to be the first bevacizumab biosimilar submitted for consideration in the United States, the reference product’s manufacturer, Roche, sees competition brewing in Europe—the European Medicines Agency has confirmed that it is currently considering 2 applications for bevacizumab biosimilars.

Roche, in attempting to retain its hold on the $6.8 billion bevacizumab market, has asserted that its patent protection for bevacizumab extends until 2019. The firm filed a complaint in the US courts in response to Amgen and Allergan’s application, and seeks to bar the biosimilar product from the US market until the patent dispute has been resolved.

Roche’s argument hinges upon the so-called “patent dance” requirements as laid out in the Biologics Price Competition and Innovation Act. However, after this week’s Supreme Court ruling in Sandoz v Amgen, which held that the “patent dance” is optional, Roche may be forced to change its litigation approach.