FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the Strategic National Stockpile. (https://www.fda.gov/media/138945/download) The FDA concluded, based on clinical trial data and the continuing failure of treatment guidelines to support use of CQ or HCQ to treat patients with COVID-19, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

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