0910-AI14 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Biologics Regulation Modernization

FDA’s biologics regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 601 42 U.S.C. 262 42 U.S.C. 301, et seq. Yes

As biologics regulations were primarily drafted in the 1970s, before passage of the BPCI Act, the regulations need to be updated and modernized to account for the existence of biosimilar and interchangeable biological products. The intent of this rulemaking is to make high priority updates to FDA’s biologics regulations with the goals of (1) providing enhanced clarity and regulatory certainty for manufacturers of both originator and biosimilar/interchangeable products and (2) help prevent the gaming of FDA regulatory requirements to prevent or delay competition from biosimilars and interchangeable products.  

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FDA’s authority for this rule derives from the biological product provisions in section 351 of the PHS Act (42 U.S.C. 262), and the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301, et seq.) applicable to biological products.

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FDA would continue to rely on guidance and one-on-one communications with sponsors through formal meetings and correspondence to provide clarity on existing requirements and procedures related to Biologic License Applications, increasing the risk of potential confusion and burden.

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This proposed rule would impose compliance costs on affected entities to read and understand the rule and to provide certain information relevant to the regulation. The provisions in this proposed rule would reduce regulatory uncertainty for manufacturers of originator and biosimilar and interchangeable products. This reduction of uncertainty may lead to time-savings to industry and cost-savings to government due to better organized and more complete BLAs and increased procedural clarity and predictability.

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]]> NPRM 08/00/2022 Undetermined None Undetermined No No Sandra Benton Senior Policy Coordinator 0910 Food and Drug Administration FDA 301 796-1042 sandra.benton@fda.hhs.gov 10903 New Hampshire Avenue, Building 22, Room 1132, Silver Spring MD 20993