Alison Siedor

Goodwin

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Latest Posts › Interchangeability

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more

9/26/2023 / Biosimilars , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Labeling , Pharmaceutical Industry , Prescription Drugs , Product Labels , Warning Labels

Is it Biosimilar or Interchangeable? It Won’t Be Easy to Tell Under FDA’s Latest Draft Labeling Guidance

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA...more

9/25/2023 / Biosimilars , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Labeling , Pharmaceutical Industry , Prescription Drugs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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