SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.”

This guidance describes FDA's interpretation of the provision of the BPCI Act under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the “deemed to be a license” provision in section 7002(e) of the BPCI Act for biological products that are approved under section 505 of the FD&C Act as of March 23, 2020 (the transition date). This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under section 505 of the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of section 7002(e) of the BPCI Act.

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. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act clarified 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),” and describing procedures for submission of a marketing application for a “biological product.” FDA previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended definition of “biological product” (see FDA's draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” available on FDA's website at https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm). Elsewhere in this issue of the Federal Register , FDA also has issued a proposed rule to amend its regulation that defines “biological product” to incorporate changes made by the BPCI Act, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” When final, this regulation will codify FDA's interpretation of these terms.

The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act). Among other things, while section 7002(e)(4) of the BPCI Act explicitly provides that an approved application under section 505 of the FD&C Act shall be deemed to be a license on March 23, 2020, the statute does not provide a means for deeming an approved new drug application (NDA) to be an approved biologics license application (BLA) prior to, or after, the transition date. Therefore, FDA interprets section 7002(e) of the BPCI Act to plainly mean that, on March 23, 2020, only approved NDAs will be deemed to be BLAs. After March 23, 2020, the Agency will not approve any application submitted under section 505 of the FD&C Act for a biological product subject to the transition provision that is pending or tentatively approved. Such an application may, for example, be withdrawn and submitted under section 351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance, FDA provides recommendations to minimize the impact on development programs for any proposed biological products intended for submission under section 505 of the FD&C Act that may not be able to receive final approval by March 23, 2020.

In the Federal Register of March 14, 2016 (81 FR 13373), FDA announced the availability of the draft of this guidance. FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. This final guidance explains that FDA interprets section 7002(e) of the BPCI Act and section 351 of the PHS Act to mean that an approved NDA for a biological product that will be deemed to be “licensed” under section 351(a) of the PHS Act on March 23, 2020, can be a reference product for a proposed biosimilar product or a proposed interchangeable product (see section 351(i)(4) of the PHS Act). However, a biological product that was first approved in an NDA under section 505 of the FD&C Act and deemed “licensed” under section 351(a) of the PHS Act on March 23, 2020, will not have been “first licensed under subsection (a)” for purposes of section 351(k)(7) of the PHS Act. Thus, such a biological product will not be eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS Act. Moreover, FDA interprets the limitations on eligibility for reference product exclusivity in section 351(k)(7)(C) of the PHS Act to apply to any reference product. The guidance also clarifies the Agency's approach to supplements submitted to an approved NDA for a biological product before March 23, 2020, that are pending on the transition date.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.” It does not ( printed page 63898) establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 has been approved under OMB control number 0910-0014; the collection of information in 21 CFR part 314 has been approved under OMB control number 0910-0001; the collection of information in 21 CFR part 601 has been approved under OMB control number 0910-0338; and the collection of information for applications submitted under section 351(k) of the PHS Act has been approved under OMB control number 0910-0719; the collection of information in FDA's guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” has been approved under OMB control number 0910-0802; and the collection of information in FDA's guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” has been approved under OMB control number 0910-0429.

III. Electronic Access

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, https://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm, or https://www.regulations.gov.