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

Regulatory NewsRegulatory News
| 27 June 2019 | By Zachary Brennan 

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. To help facilitate the seamless transition of these products, we’re focused on advancing policies, like today’s proposed rule, to provide clarity and predictability, and minimize burden for transitioning products – without compromising the quality, safety or efficacy of the products,” Sharpless said.

The reason for allowing these approximately 17 NDAs, which include reproductive hormones and enzymes, to rely on DMFs after the transition is because they were approved by FDA based in part on the drug substance, drug substance intermediate or drug product information contained in those DMFs.

But after the transition, FDA notes, a proposed biosimilar and/or interchangeable biosimilar to one of these transitioned biologics may not reference the DMF for the drug substances, drug substance intermediates or drug products information, consistent with FDA’s existing practice for biologics submitted in Biologics License Applications (BLAs) and the use of DMFs.

The proposed rule also would codify FDA’s existing practice that information from a master file, including drug substance, drug substance intermediate or drug product information, may be relied on at the investigational phase of development for a biologic product subject to licensure under the Public Health Service Act. It also codifies FDA’s existing practice that a biologic in a BLA may rely on a master file, except for information regarding a drug substance, drug substance intermediate or drug product.

Proposed Rule

“Deemed to be a License” Provision of the BPCI Act


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