FDA Approves ZIRABEV, Pfizer’s Bevacizumab Biosimilar Product

Today, June 28, 2019, the FDA approved Pfizer’s aBLA for ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN. According to its approved package insert, ZIRABEV is indicated for the treatment of metastatic colorectal cancer in combination with certain types of chemotherapy as described on the label.

ZIRABEV is the twenty-first biosimilar product overall to obtain FDA approval and the second bevacizumab biosimilar, following Amgen’s MVASI (bevacizumab-awwb) in September 2017.

Pfizer is currently engaged in BPCIA litigation against Genentech regarding its bevacizumab biosimilar.  According to the complaint in that action, Pfizer already served a notice of commercial marketing pursuant to § (l)(8)(A), that notified Genentech of Pfizer’s “intent to begin commercial marketing of its aBLA product as early as July 17, 2019 (180 days from the date of the notice).”