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 the drugs selected in the first round of drug price…
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 Again Putting Americans First.” Then, on May 12, 2025, President…
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 under approval), are each intended for distinct therapeutic indications. According…
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 biosimilar of Janssen’s STELARA® (ustekinumab) in a breach of contract…
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…
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…
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…
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…
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….
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…