BIO Submits Comments on FDA on Biosimilars Q&A Draft Guidance
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May 2015)” (“Q&A Draft Guidance”).</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May 2015)” (“Q&A Draft Guidance”).
The implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is of significant importance to BIO members, and we appreciate FDA’s continued work to implement the Act. We also commend FDA’s efforts, through mechanisms such as this Q&A Draft Guidance, to provide crucial insight into the Agency’s current thinking on many important aspects of the law. BIO has previously commented on biosimilars issues and appreciates FDA’s consideration of our comments. We are pleased to provide general comments on the Q&A Draft Guidance and also to provide recommendations on additional topics for consideration in future guidance.
