The U.S. Food and Drug Administration has issued a guidance document titled “Q&As on Biosimilar Development and the BPCI Act.”
This guidance provides FDA’s current thinking on regulatory and scientific considerations for developing biosimilar products under the Biologics Price Competition and Innovation Act (BPCI Act).
The Q&A format clarifies regulatory expectations for sponsors seeking approval of biosimilars under section 351(k) of the Public Health Service Act.
🔍Key points:
Explains the statutory framework established by the BPCI Act for the abbreviated biosimilar approval pathway.
Clarifies the “totality of evidence” approach used by FDA to determine biosimilarity, including analytical, nonclinical, and clinical data.
Emphasizes the importance of analytical similarity assessments, which form the foundation of biosimilar development programs.
Addresses requirements for reference product selection, including circumstances where non-U.S. comparators may be used with appropriate bridging data.
Explains the regulatory distinction between biosimilarity and interchangeability, including the higher evidentiary standard required for interchangeable designation.
Describes the exclusivity framework for reference biologics, including the 12-year reference product exclusivity period and the 4-year submission restriction for biosimilar applications.
Document:
https://lnkd.in/eHBYicdQ