Biosimilars Market Is Becoming More Active but Still Faces Issues

  • Jul 11, 2024

    In May, the FDA approved three interchangeable biosimilars that were the first for their reference drugs. With an additional three approvals in June, that brings the total number of biosimilars to 57 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With the three agents approved in May also gaining interchangeability status, that brings the count of interchangeable biosimilars to 15. While the market is certainly heating up, it still is grappling with issues such as expected rebates, maintains one industry expert.

    On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy). On June 28, the FDA approved a third Eylea biosimilar, Formycon AG and Klinge Biopharma GmbH’s Ahzantive (aflibercept-mrbb) for the same indications as the first two agents, but it does not have interchangeable status.

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  • Angela Maas

    Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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