Zachariah Holmes Ph.D.

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Latest Posts › Interchangeability

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Celltrion Adalimumab Biosimilar Granted Interchangeability Designation

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). ...more

4/21/2025 / Biosimilars , Celltrion , FDA Approval , Food and Drug Administration (FDA) , Interchangeability , Pharmaceutical Industry , Pharmaceutical Patents

FDA Approves First Interchangeable Biosimilar Insulin Product - Update

July 28, 2021 - the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press...more

11/24/2021 / Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Intellectual Property Litigation , Intellectual Property Protection , Interchangeability , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Breaking News – FDA Approves First Interchangeable Biosimilar Insulin Product

Today the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release,...more

7/29/2021 / Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Interchangeability , Life Sciences , Pharmaceutical Industry

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