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Big Molecule Watch

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By: Goodwin Procter

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Sean Anderson
Beth Ashbridge
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Beth Ashbridge|Kevin DeJong

Latest from Big Molecule Watch

Big Molecule Watch

EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars

By Alison Siedor
May 9, 2025

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

District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case

By Riley Wyberg
May 2, 2025

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…

Big Molecule Watch

EmblemHealth Files Class Action Antitrust Against Alexion Related to Eculizumab

By Sam Herron
April 30, 2025

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…

Big Molecule Watch

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

By Beth Ashbridge
April 30, 2025

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…

Big Molecule Watch

Update on Regeneron’s Supplemental BLA for EYLEA HD

By Daniel Farraye
April 29, 2025

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…

Big Molecule Watch

Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation

By Allegra Padula
April 28, 2025

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). …

Big Molecule Watch

Celltrion Adalimumab Biosimilar Granted Interchangeability Designation

By Zachariah Holmes
April 18, 2025

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…

Big Molecule Watch

FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs

By Darlene Staines
April 15, 2025

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.” …

Big Molecule Watch

FDA Approves Biocon Biologics’ Bevacizumab Biosimilar

By Darlene Staines
April 11, 2025

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…

Big Molecule Watch

Teva and Samsung Bioepis Announce U.S. Launch of EPYSQLI® (eculizumab-aagh), a SOLIRIS® Biosimilar

By Darlene Staines
April 9, 2025

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®,…

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