FDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposes omitting comparative efficacy studies (CES) where appropriate “based on the totality of the evidence” to instead rely only on analytical, PK/PD, and immunogenicity data to inform biosimilarity determinations. As the agency explains, it has gained substantial experience with comparative analytical assessments (CAA) and now wants to update its framework for determining when a CES may not be necessary to support biosimilarity.
