FDA Proposes Doing Away With Biosimilar Switching Studies for Interchangeability

  • Jul 11, 2024

    When the biosimilar pathway was first established, it created a two-tier system of biosimilars and interchangeable biosimilars, but multiple attempts have been made recently to level the playing field. In the latest move, the FDA proposed doing away with switching studies for interchangeables. But while the move could bring biosimilars onto the U.S. market faster and result in more competition, industry efforts are divided about whether it could prompt broader payer uptake.

    As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

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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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