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We are pleased to share the 13th edition of our Biosimilar Market Report, providing updated analysis of US pricing and market share trends across biosimilar markets.
The regulatory environment for biosimilar approval continues to evolve. Over the past year, FDA has issued two notable draft guidance updates: an October 2025 draft indicating that comparative efficacy studies (CES) may no longer be routinely expected, and a March 2026 revision introducing additional flexibility in the use of non-US-licensed comparator data. Together, these updates reflect a broader shift toward greater emphasis on analytical and pharmacokinetic evidence in demonstrating biosimilarity.
In this quarter’s report, we review these regulatory developments and assess the potential implications for biosimilar development and the US market. We also highlight perspectives from recent payer and provider market research to provide additional context on how these developments may be perceived across stakeholders.
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