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FDA Moves to Facilitate Biosimilar Development

FDA Moves to Facilitate Biosimilar Development

Oct 30, 2025 | Op-Eds

Yesterday, the Food and Drug Administration (FDA) announced long-overdue reforms to the biosimilar approval process that will boost biosimilar development and competition in the United States.

Alex Brill Interviewed by Biosimilars Review & Report

Alex Brill Interviewed by Biosimilars Review & Report

Aug 6, 2025 | Interviews

Following the release of the new MGA white paper “The Long-Term Effects of Medicare Price Negotiations on Drug Competition,” Alex Brill spoke with Stanton Mehr at Biosimilars Review & Report.

New MGA Paper Identifies Barriers to US Biosimilar Success in the Second Decade

New MGA Paper Identifies Barriers to US Biosimilar Success in the Second Decade

Mar 5, 2025 | Analysis

Alex Brill and Christy Robinson look at the US biosimilars market a decade after the first biosimilar approval.

Despite Headwinds, Biosimilars Market Is Growing in 2024

Despite Headwinds, Biosimilars Market Is Growing in 2024

Jul 8, 2024 | Commentary

The Food and Drug Administration (FDA) has approved a record number of biosimilars in 2024, and the year is only half over.

Current and Future State of US Biosimilars

Current and Future State of US Biosimilars

Apr 24, 2024 | Commentary

Fourteen years ago, Congress established a regulatory pathway for biosimilars, direct competitors to branded biologic drugs.

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  • Books (3)
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  • Events (21)
  • Interviews (60)
  • News (55)
  • Op-Eds (100)
  • Press Releases (4)
  • Testimony (21)
  • Government’s Drug Negotiation Program
    Diminishing Returns from the Government’s Drug Negotiation ProgramJanuary 29, 2026
  • ACA Tax Credit Extension Matter
    Would Senate Passage of an ACA Tax Credit Extension Matter?January 14, 2026
  • PBMs Pass Through Rebates
    MGA Brief Examines State and Federal PBM MandatesDecember 1, 2025
  • FDA Moves to Facilitate Biosimilar Development
    FDA Moves to Facilitate Biosimilar DevelopmentOctober 30, 2025
  • How Pharmaceutical Tariffs Will Affect US Health Care Costs
    How Pharmaceutical Tariffs Will Affect US Health Care CostsSeptember 26, 2025
  • Quantifying the economic impact of healthcare distributors
    MGA Releases New Report Quantifying the Economic Impact of Healthcare DistributorsSeptember 17, 2025
  • Unsung Hero of the OBBBA
    The Unsung Hero of the OBBBA: Permanent ExpensingAugust 20, 2025
  • Alex Brill Interviewed by Biosimilars Review & Report
    Alex Brill Interviewed by Biosimilars Review & ReportAugust 6, 2025
  • Medicare Price Negotiations and Drug Competition
    MGA Releases New White Paper on Medicare Price Negotiations and Drug CompetitionJuly 14, 2025
  • effects of 304B
    The 340B Program’s Negative Impact on Pharmaceutical InnovationJune 5, 2025
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