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EMA Adopts Positive Opinions for Multiple Biosimilars

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

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:...more

FDA Approves First Rapid-Acting Insulin Biosimilar Product for the Treatment of Diabetes

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

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