On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages.
As we reported previously, Regeneron filed its antitrust lawsuit in 2022 in
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Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI (ustekinumab-aekn) with STELARA (ustekinumab)
On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab). SELARSDI is approved for all indications matching the reference product,…
Join Us! The Future of Biotech Regulation Webinar
By Sarah Clarke
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…
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…
Antitrust Life Sciences Quarterly Update 2025 Q1
While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration. The Federal Trade Commission (FTC) under…
Most Favored Nation Drug Pricing Executive Order Resurrects Prior President Trump Policy
On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. This latest Executive Order simultaneously pushes key stakeholders (i.e. foreign governments and drug manufacturers) to modify their…
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…