FDA takes new step to help advance the transition of certain biological products

The Food and Drug Administration has provided an update and proposed rule related to the work it has been doing to transition biological products approved under the Federal Food, Drug, and Cosmetic Act as drug products to be deemed licensed as biologics under the Public Health Service Act on March 23, 2020. It’s a shift, said FDA, that ultimately means opening specific products up to competition through the biosimilars pathway.

Acting FDA Commissioner Ned Sharpless said in a statement that this would include insulin, which has been historically regulated as a drug and not a biologic. As FDA moves closer to the upcoming transition date, the agency says its work has been focused on a variety of coordinated steps that will help ensure a seamless transition with minimal impacts to the makers of these products or patients who rely on them.

“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,” Sharpless said. “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. The proposed rule is intended to help mitigate any unintended consequences of the transition, including the potential for drug shortages, if manufacturing were to be disrupted.”

Some of the applications (approximately 17, such as reproductive hormones and enzymes) that will be transitioned currently incorporate reference information contained in DMFs to support their application and were approved by the FDA based in part on the drug substance, drug substance intermediate or drug product information contained in those DMFs. FDA says many of these products have been marketed for decades and over this period, none of these products have been withdrawn or removed from the market for reasons of safety or effectiveness. For these products, the FDA says it has no reason to believe that the March 23, 2020, transition in and of itself introduces new risks to product safety, purity and potency.

The proposed rule amends FDA regulations on the use of master files for biological products and if finalized would:

·  allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020

·  codify the FDA’s existing practice that an application for a biological product under the PHS Act may rely on a master file, except for information on drug substances (active pharmaceutical ingredient, or API), drug substance intermediates (a material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API), or drug products (finished dosage forms, such as tablets or capsules)

·  codify the 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 product subject to licensure under the PHS Act