Lexology December 3, 2025
In Short
The Development: The Food and Drug Administration (“FDA”) issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate biosimilar development.
The Result: If the draft guidance documents are finalized as written, the policy changes effectively collapse the distinction between biosimilarity and interchangeability and would likely accelerate biosimilar approvals. High-quality analytical comparability, paired with pharmacokinetic (“PK”) and immunogenicity assessments, will generally suffice; clinical efficacy and switching studies would become the exception, at least for therapeutic proteins.
Looking Ahead: In early 2026, FDA plans to finalize the guidance documents to align the biosimilars pathway more with the generics model, and may begin approving all...
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