FDA Announces Measures to Accelerate Biosimilar Development and Reduce Drug Costs
11/12/2025 (US FDA Published: October 29, 2025)
To support faster and more cost-effective biosimilar development, the FDA released a new draft guidance. Biosimilars are lower-cost “generic” alternatives to biologic drugs used to treat conditions such as cancer and autoimmune diseases. The updated guidance recommends relying on analytical testing rather than requiring comparative efficacy studies, which have traditionally been resource-intensive. This change is expected to significantly reduce development time and costs.
Additionally, the FDA now generally does not recommend “switching studies” for biosimilars seeking interchangeable status, a requirement that has previously slowed development and caused confusion.
Despite the FDA having approved 76 biosimilars, they represent only a small fraction of approved biologics, and their market share remains below 20%. The FDA’s reform aims to help more companies bring high-quality, affordable biosimilars to market, thereby reducing healthcare costs and expanding patient options.
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