Alison Siedor

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Latest Posts › FDA Approval

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Commercialization of Ustekinumab and Golimumab Biosimilars

This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia....more

4/4/2025 / Biosimilars , Drug Pricing , FDA Approval , Food and Drug Administration (FDA) , License Agreements , Pharmaceutical Industry , Prescription Drugs

RELEUKO Receives FDA Approval

Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as...more

3/10/2022 / Biosimilars , FDA Approval , 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

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