FDA Approves Amgen’s Biosimilar of Avastin®

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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.)

The FDA’s announcement today follows the unanimous recommendation of an FDA advisory panel in July to approve Amgen’s biosimilar product.  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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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