Zachariah Holmes Ph.D.

Goodwin

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Latest Posts › Biologics

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FDA Accepts BLA for Dr. Reddy’s Rituximab Biosimilar for Review

On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN...more

7/21/2023 / Biologics , Biosimilars , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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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