Search Results: U.S. FDA News

FDA Approves Amgen's WEZLANA As Biosimilar to and Interchangeable With Janssen's STELARA (ustekinumab) - Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab).  WEZLANA is the first product to be approved as a biosimilar to STELARA.  As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….

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FDA to Review Vertex Pharmaceutical’s Application for CRISPR-based Gene Therapy Exa-cel

The Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA is meeting tomorrow, Tuesday, October 31, 2023, to review a Biologics License Application by Vertex Pharmaceuticals Inc. for exagamglogene autotemcel (exa-cel).  Exa-cel is a cell-based gene therapy product composed of the patient’s own hematopoietic stem and progenitor cells (HSPCs) edited…

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Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small…

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FDA Approves Regeneron’s 8 mg injection of EYLEA (aflibercept) and VEOPOZ (pozelimab)

Bottle of Pills and a FDA APPROVED rubber stamp

On August 18, 2023, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced that the FDA approved EYLEA HD®, an 8 mg injection of EYLEA® (aflibercept).  EYLEA HD®, jointly developed with Bayer A.G., is approved for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).  EYLEA® was…

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FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.

Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.”  The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background,…

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FDA Announces New Draft REMS Guidance

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged…

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FDA Releases Biosimilars Educational Materials

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved.  The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars.  FDA also created social media posts for external…

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FDA Announces Biosimilar User Fee Act Rates for FY2018

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018.  The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017.  Among other things,…

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