Alison Siedor on Food and Drug Administration (FDA)

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

Celltrion Submits BLA for Omalizumab Biosimilar

Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product...more

3/18/2024 / Biosimilars , Celltrion , Food and Drug Administration (FDA) , Patents , Pharmaceutical Industry , Pharmaceutical Patents

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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more

9/26/2023 / Biosimilars , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Labeling , Pharmaceutical Industry , Prescription Drugs , Product Labels , Warning Labels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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for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9/25/2023 / Biosimilars , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Labeling , Pharmaceutical Industry , Prescription Drugs

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

Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung...

Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more

11/24/2021 / aBLA , Biologics , Biosimilars , Food and Drug Administration (FDA) , Patents , 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

FDA Approves Interchangeable Status for BI’s Adalimumab Biosimilar Cyltezo

BI’s adalimumab biosimilar CYLTEZO (adalimumab-adbm) has recently been granted interchangeable status by the FDA. Although approved in August 2017, CYLTEZO is not scheduled to launch until July 1, 2023, pursuant to a...more

10/19/2021 / Biosimilars , Drug Interchangeability and Dispensing Fee Act (DIDFA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Alison Siedor

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