Pfizer Launches Bevacizumab Biosimilar, Zirabev, in the United States

Pfizer announced Monday that its bevacizumab biosimilar, Zirabev, has launched and will be available next week.

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said. In an email to The Center for Biosimilars^®, a company spokeswoman said "the medication will be available for shipment from Pfizer the week of January 13."

The biosimilar was approved in June 2019 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.

It 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.

Last year, attorneys for both Genentech, which sells Avastin, and Pfizer entered a joint stipulation of dismissal of their patent litigation over bevacizumab. The stipulation stated 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.

News about the next bevacizumab biosimilar is not expected until later in the year. Last November, the FDA accepted for review SB8, a proposed bevacizumab biosimilar from Samsung Bioepis.