On April 16, 2025, EmblemHealth, Inc. (“Emblem”) filed a class action suit in the District Court for the District of Massachusetts against Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) alleging Alexion “violated antitrust law by monopolistic acts that unlawfully delayed the introduction of biosimilar competition for eculizumab.”  Enblem alleges that Alexion…

This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). DAZUBLYS, a 150 mg powder for concentrate for solution for infusion product, specifically binds and inhibits the human…

On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD (aflibercept).  The supplemental application is for the addition of extended dosing intervals (up to every 24 weeks) of EYLEA HD injection 8 mg across all approved…

On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re: Aflibercept Patent Litigation (MDL No.: 1:24-md-3103).  The stipulation had been filed the day before by Plaintiff Regeneron Pharmaceuticals, Inc. and Defendants…

On April 14, 2025, Celltrion, Inc. announced that the U.S. Food and Drug Administration granted an interchangeable designation to YUFLYMA (adalimumab-aaty), its biosimilar referencing HUMIRA (adalimumab).  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider.
YUFLYMA is FDA approved for the…

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them “with more effective, human-relevant methods.”  According to the FDA, the “animal testing requirement will be reduced, refined, or potentially replaced…

On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN®.  JOBEVNE is a recombinant humanized monoclonal antibody that acts as a vascular endothelial growth factor inhibitor.  It is indicated for the treatment of certain types of colorectal cancer, non-squamous…