In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance.

The update added five questions, including:

  • Sponsor responsibilities related to pediatric assessments for proposed biosimilar products
  • The types of information needed to support post-approval manufacturing changes
  • Clarification that sponsors may not seek approval for a biosimilar with a different route of administration, dosage form, or strength than the reference product
  • Clarification that biosimilars cannot be approved for conditions of use that have not previously been approved for the reference product.
  • An explanation that sponsors should provide data and information to support the approval of a proposed biosimilar for an indication still covered by unexpired or orphan exclusivity (though the indication will not be approved until the orphan exclusivity expires).

In addition, several questions were withdrawn, while others underwent minor editorial changes.

Learn more about the updated guidance here. 

Read the guidance here.