On May 14, The Food and Drug Administration released an additional series of questions and answers regarding the ongoing implementation of the Biologic Price Competition and Innovation Act of 2009.
On May 14, The Food and Drug Administration released an additional series of questions and answers regarding the ongoing implementation of the Biologic Price Competition and Innovation Act of 2009.
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In 2010 the Food and Drug Administration (FDA) began the process of collecting public comments on the issues and challenges associated with the abbreviated licensure pathway for approval of biosimilars biologic products that was created by the Biologic Price Competition and Innovation Act of 2009 (BPCI). Since then the FDA has issued a series of formal and informal guidance documents intended to assist sponsors, holders of Biological License Applications, and other interested stakeholders in understanding the responsibilities and obligations associated with the BPCI pathway. While FDA guidance documents do not establish enforceable responsibilities, they do describe the FDA’s current thinking on topics and can serve as recommendations for sponsors and other interested stakeholders.
The document released on May 14 updated a list of question and answers which the FDA believes may arise during the development of a biosimilar biologic product. The May 14th guidance provides recommendation on issues related to biosimilarity and interchangeability, provision related to the submission of an application, and issues surrounding the exclusivity provisions of BPCI.
Stakeholders are encouraged to review the draft guidance documents and submit comments to the FDA by July 13th by following the directions in the Federal Register notice. Click here for the full notice.
The FDA guidance document is available here.
