Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates.
The two candidates, VEVZUO and Denosumab BBL (the brand name is currently
Big Molecule Watch
Blog Authors
Latest from Big Molecule Watch
District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case
On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”) from launching a private label…
EmblemHealth Files Class Action Antitrust Against Alexion Related to Eculizumab
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…
CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe
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…
Update on Regeneron’s Supplemental BLA for EYLEA HD
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…
Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation
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). …
Celltrion Adalimumab Biosimilar Granted Interchangeability Designation
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…
FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs
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.” …
FDA Approves Biocon Biologics’ Bevacizumab Biosimilar
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…
Teva and Samsung Bioepis Announce U.S. Launch of EPYSQLI® (eculizumab-aagh), a SOLIRIS® Biosimilar
On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®. As we reported in January, Teva and Samsung Bioepis entered into a strategic partnership regarding EPYSQLI®,…