As part of Goodwin’s webinar series, What’s Next: Life Sciences at a Crossroads, Matthew Wetzel and Elizabeth Mulkey will be diving into highlights from the Trump 47 Executive Orders on Lowering Drug Prices and Increasing Domestic Manufacturer and Regulatory Relief
Big Molecule Watch
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Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing the Program. AstraZeneca manufactures Farxiga, one of…
President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs
By Publisher
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO 273”), titled “Lowering Drug Prices By Once…
EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars
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…
District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case
By Riley Wyberg
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
By Sam Herron
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…