FDA Guidance for the Industry
Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 – Guidance for Industry
This draft guidance describes FDA’s approach to implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) on or before March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020.
Specifically, this draft guidance describes FDA’s interpretation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that have been or will be approved under the FD&C Act on or before March 23, 2020.
This draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA’s interpretation the transition provisions of the BPCI Act.
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Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act (see the Appendix to this guidance for examples of such products).
On March 23, 33 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Public Law 111-148). The BPCI Act changed the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” in section 351(i) of the PHS Act to include a “protein (except any chemically synthesized polypeptide).”
Products under Section 351(k) of the PHS Act
A sponsor of a proposed biological product that could meet the requirements for a proposed biosimilar and other applicable requirements would be able to submit a 351(k) BLA that cites the listed drug as its reference product after the NDA for the listed drug is deemed to be a BLA (or after another product that could be a reference product for the proposed product is licensed under section 351(a) of the PHS Act).
- is “highly similar” to a single reference product licensed under section 351(a) of the PHS Act, and that there are “no clinically meaningful differences” between the proposed product and the reference product in terms of safety, purity, and potency
- has the same route of administration, dosage form, and strength as the reference product
- utilizes the same mechanism(s) of action as the reference product for the proposed condition(s) of use (but only to the extent that the mechanism(s) of action are known)
- seeks licensure for a condition(s) of use
Download FDA Guidance in PDF
Last Updated: 2016-03-14