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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.