Zachariah Holmes Ph.D. on Food and Drug Administration (FDA)

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 Ustekinumab, Aflibercept, and Filgrastim Biosimilars

On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab)....more

7/9/2024 / Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Denosumab Biosimilar Updates - June 2024

On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more

6/4/2024 / Amgen , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Fresenius , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs , Refusal-to-License

FDA Approves LOQTORZI in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma

On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi) in combination with cisplatin and gemcitabine for...more

11/1/2023 / FDA Approval , Food and Drug Administration (FDA) , Prescription Drugs

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

USPTO Extends Deadline for Comments on USPTO-FDA Collaboration Initiatives

On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023....more

3/1/2023 / Biden Administration , Comment Period , Executive Orders , Food and Drug Administration (FDA) , Patents , Pharmaceutical Industry , USPTO

Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving...more

9/9/2022 / Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Fresenius , Prescription Drugs

Draft Senate Legislation Expands FDA’s QIDP Designation

On Tuesday, January 25, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair, Senator Patty Murray (D-WA), and Ranking Member, Senator Richard Burr (R-NC) released a discussion draft of the Prepare for and...more

2/14/2022 / Congressional Committees , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Infectious Diseases , Proposed Legislation , Public Health

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

Zachariah Holmes Ph.D.

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