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USFDA finalizes Q&As on Biosimilar Development

US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act (BPCIA) and updated numerous questions within the document.

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).


The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.


FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products.


In addition, these Q&As respond to questions the Agency has received from applicants regarding the submission of biologics license applications (BLAs) for biosimilar and interchangeable products. FDA intends to update this final guidance document to include additional Q&As as appropriate.

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