USA – FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

The US Food and Drug Administration (FDA) on Thursday proposed a new rule to allow certain biologics, originally approved under a new drug application (NDA), to continue relying on drug master files (DMFs) for certain information even after the NDA is deemed to be a license for a biological product on 23 March 2020.

This so-called “deemed to be a license” transition next year, the details of which were explained in full last December, will mean that moving forward, follow-on applicants will not be able to rely upon these NDAs and win approval as generics but will have to win approval as biosimilars. 

Acting FDA Commissioner Ned Sharpless explained the new proposed rulemaking: “We have identified approximately 89 approved new drug applications that will transition on March 23, 2020; approximately 17 of them incorporate certain information related to the drug and its components in documents known as drug master files.

“While this is a technical detail for a limited number of products, this presents a complication for the transition since under our current practice, licensed biologics are not permitted to reference master files for this type of information…