On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more
3/7/2025
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Preliminary Injunctions
On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to...more
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