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EMA’s CHMP Recommends Approval of Six New Biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars....more

Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA...

As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more

Celltrion Announces FDA Approval of ZYMFENTRA (infliximab-dyyb)

On October 23, 2023, Celltrion announced FDA approval for ZYMFENTRA (infliximab-dyyb), a subcutaneous formulation for maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease....more

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