FDA Releases Q&A on Biosimilars

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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.


FDA has release a draft guidance Q&A document that addresses questions related to the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The draft guidance applies to the development of biosimilar products and biologics license application (BLA) holders. Topics addressed in the guidance include biosimilarity, requirements for submission of a BLA, and exclusivity. 

The draft guidance revises the 2012 draft guidance and presents new questions and answers that have yet to be finalized. New questions answered by FDA in regards to biosimilarity include:


  • How can a proposed biosimilar product applicant fulfill the requirement for pediatric assessments under the Pediatric Research Equity Act?

  • When should a proposed biosimilar product applicant submit an initial pediatric study plan?

  • For biological products intended to be injected, how can an applicant demonstrate that its proposed biosimilar product has the same “dosage form” as the reference product?

  • If a non-US-licensed product is proposed for importation and use in the United States in a clinical investigation intended to support a proposed biosimilar development program, is a separate investigational new drug application required for the non-US-licensed product?

FDA also addresses the marketing application requirements that should be submitted for a proposed antibody-drug conjugate, as well as the requirements for a request for reference product exclusivity.

The draft guidance is a part of a series developed to implement the BPCI Act, which was enacted as part of the Affordable Care Act.

Source: FDA.gov