In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more
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:...more
4/29/2025
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Biosimilars ,
BPCIA ,
Dismissal With Prejudice ,
FDA Approval ,
Hatch-Waxman ,
Multidistrict Litigation ,
Mylan Pharmaceuticals ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron ,
Settlement Agreements
On February 14, 2025, the U.S. Food and Drug Administration (“FDA”) approved Sanofi-Aventis U.S. LLC’s (“Sanofi”) MERILOG™ (insulin-aspart-szjj), a biosimilar to Novo Nordisk A/S’s (“Novo Nordisk”) NOVOLOG® (insulin aspart),...more