Pfizer Confirms It Plans to Launch Bevacizumab Biosimilar on December 31

In an email to The Center for Biosimilars^®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.

Earlier this month, attorneys for both Genentech and Pfizer entered a joint stipulation of dismissal of their patent litigation in the case. The stipulation states that the parties are voluntarily dismissing all claims and counterclaims of an April 2019 complaint without prejudice.

In the original complaint, Genentech alleged that Pfizer had not produced all necessary information concerning the biosimilar to Genentech, and also claimed that the biosimilar would infringe 23 of its patents.

These developments clear the way for Pfizer to commercialize the biosimilar, which was approved in June of this year by the FDA for the treatment of metastatic colorectal cancer, recurrent or metastatic nonsquamous non—small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.

The biosimilar, referencing Avastin, also earned the European Commission’s approval in February 2019 after having received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2018.

Zirabev will join 1 other biosimilar bevacizumab in the US market; in July of 2019, Amgen launched its bevacizumab biosimilar, Mvasi, on the same day as it launched a biosimilar trastuzumab, Kanjinti. In Amgen’s case, no settlement was reached, and legal disputes over Mvasi are ongoing.

Last month, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal. The appeal relates to the court’s decision that Amgen did not need to provide Genentech with new notice of commercial marketing after filing supplements to its Biologics License Application. A trial in the case is expected in 2020.