Biosimilars - Additional Q&A Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

Additionally to the Guidelines on the development of Biosimilars published in April, the FDA issued a draft Guidance for Industry "Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009" in May. This guidance revises the 2012 draft guidance on Biosimilars: Questions and  Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of  2009 to provide new and revised questions and answers. It also includes certain original questions and answers that have not yet been finalized.

In their Introduction, the FDA explains:

"The Q&A 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. In addition, these Q&As respond to questions the Agency has received from prospective BLA and new drug application (NDA) applicants regarding the appropriate statutory  authority under which certain products will be regulated. FDA intends to update this guidance to  include additional Q&As as appropriate. A Table describes the status of the draft guidance Q&As provided in this guidance and final guidance Q&As that are included in the guidance on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. FDA has maintained the original numbering of the 63 Q&As used in the February 2012 draft guidance. Q&As that have been finalized appear in the final guidance, and the omission of these Q&As from this revised draft guidance is marked by several asterisks between nonconsecutively numbered Q&As."

See here the complete guidance Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.