FDA Approves Amgen’s Biosimilar of Avastin® (UPDATED)

Today, the FDA announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®.  According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer.  Mvasi® is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer, which are most but not all of the same cancers for which Avastin® is approved.  (See the approved labeling for Mvasi® and Avastin® for additional details.)

According to a separate press release, Mvasi® is the first product to be approved by the FDA from a collaboration between Amgen and Allergan, which are collaborating on the development and commercialization of four oncology biosimilars, including Mvasi®.

The FDA’s approval of Mvasi® today follows the unanimous recommendation of an FDA advisory panel in July to approve this biosimilar product, which had previously been referred to as ABP 215.  Mvasi® is the seventh biosimilar product to receive FDA approval through the 351(k) pathway, and the fourth such product in the past 12 months alone.

Amgen and Genentech are not presently engaged in any pending U.S. litigation concerning this biosimilar, though the companies previously litigated a dispute regarding the patent dance procedures of the BPCIA, but that case was dismissed back in March.

Stay tuned to Big Molecule Watch for further developments.