Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 is the final version of a draft guidance for industry originally released in 2012. It provides answers to common questions about the following topics:

  • Biosimilarity or interchangeability.
  • Provisions related to requirement to submit a biologics license application for a “biological product.”
  • Exclusivity.

As stated in the document, the question-and-answer format is intended to promote transparency and facilitate development programs for proposed biosimilar products by addressing questions that may arise in the early stages of development.

Examples of questions addressed in the guidance include:

  • Can a proposed biosimilar product have a different formulation than the reference product?
  • How does FDA interpret the category of “protein (except any chemically synthesized polypeptide)” in the amended definition of “biological product” in section 351(i)(1) of the Public Health Service Act?
  • How can a prospective biosimilar applicant determine whether there is unexpired orphan exclusivity for an indication for which the reference product is licensed?

The full document is available on the FDA website.