Regulatory Counsel

0910-AH50 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Biologics License Applications and Master Files

The Biologics Price Competition and Innovation Act of 2009 created a new category of approved products Biosimilars to encourage competition and reduced drug prices in the biologics drug market. The legislation deemed certain biologics approved under the drug provisions (NDAs) of the FD&C Act as biologics (BLAs) after March 23, 2020. These drugs were approved under the NDA provisions based on drug master files (DMF) which provide additional information about the drug substance not included in the application and with right of reference from a sponsor other drug applications can refer to these DMFs which reduces the data and work applicants may have to gather and include in the marketing application. To ensure that such right of reference can still occur after the statutorily required transition, FDA has to change its regulations to permit this continued use of DMFs and ensure no unnecessary delays or disruption to the consideration of these biosimilar products.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 601.2 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 300aa-25 Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817 No NPRM 12/00/2017 No No None No No No No Daniel Orr Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-0979 daniel.orr@fda.hhs.gov Building 51, Room 5199, 10993 New Hampshire Avenue, Silver Spring MD 20993