More Q&A guidance for biosimilars released by FDA

May 18, 2015 11:13 AM

FDA has recently finalized three guidance documents on biosimilars at the end of April. This time, FDA released an another “Question and Answer” guidance in draft form.

The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”.

This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

This guidance revises the 2012 draft guidance on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 to provide new and revised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.

The questions and answers (Q&As) are grouped in the following categories:
• Biosimilarity or Interchangeability
• Provisions Related to Requirement to Submit a BLA for a “Biological Product”
• Exclusivity

The draft guidance is published on FDA website and you can reach the document from the below link:

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

 

Source: FDA

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