FDA Issues Guidances To Advance Biosimilars Policy Framework

The US Food and Drug Administration (FDA) has released two guidances, one final and one draft, to advancie the agency’s biosimilars policy framework. The guidances describe the agency’s plan to implement Congress’ direction that the FDA transition certain biological products currently approved as drugs under Federal Food, Drug, and Cosmetic (FD&C) Act to be licensed as biologics under the Public Health Service Act (PHSA).

“Today [December 11, 2018], we’re laying out our policy on how these products will transition from the drug pathway to the biologics pathway, and in so doing, how we intend to use this new framework to promote competition,” FDA Commissioner Scott Gottlieb said in a December 11, 2018 agency statement. The draft guidance, The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers, describes how the FDA intends to accomplish the transition of these products under the “Deemed to be a License” provision of the Biologics Price Competition and Innovation (BPCI) Act. The final guidance, Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009, finalizes the FDA’s draft guidance from 2016.

“Starting in March 2020, the approved marketing applications for the small subset of ’biological products,” such as insulin and human growth hormone, which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act, will be deemed to be biologics licenses under section 351 of the PHSA,” Gottlieb said in his statement. “Sponsors have known about this transition for a decade. They’ve had time to prepare.”

Additionally, the FDA says it has shaped to clarify exclusivity provisions so as not to forestall biosimilar entry to these newly deemed products, including insulin. “…[We] wanted to make sure that as these drugs transition to the biologics pathway, they don’t receive additional exclusivities that they aren’t entitled to,” Gottlieb said in the statement. “They don’t get to start benefiting from the 12 years of exclusivity that the law grants to newly licensed biologics, just because these drugs–some of which were approved decades ago–are being treated as biologics for the first time. Once their patents have lapsed, and certain previously awarded exclusivities like orphan drug protection, have run their course, these products can be open to brisk competition from biosimilars.”

The final guidance provides recommendations to sponsors of proposed biological products that are intended for submission in a new drug application (NDA) that may not receive final approval under the drug pathway of the FD&C Act by March 2020 to consider how they can align their development plans to account for the transition provisions. Biological products that have been approved under section 505 of the FD&C Act will be removed from the FDA’s Orange Book, which publishes all FDA-approved drug products with therapeutic equivalence, on March 23, 2020, based on the agency’s position that these products are no longer “listed drugs.” Products approved in NDAs that are deemed to be biologics license applications (BLAs) will be included in the Purple Book, which lists biologics licensed by the FDA under the PHSA.

The final guidance also describes the FDA’s plans for supplements to approved NDAs that are pending under the FD&C Act on March 23, 2020. “We intend to administratively convert these pending NDA supplements to pending BLA supplements under the PHS Act,” Gottlieb said. “We’re doing this to minimize possible disruption caused by the transition provisions of the BPCIA and provide clarity and certainty to application holders who seek to make changes to their products close to the transition date.”

Source: FDA

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