Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of 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 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 are approved under the FD&C Act as of March 23, 2020. This 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 of the transition provision of the BPCI Act.
Scope & Applicability
Product Classes
7Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Proposed products intended for submission in an application; Specific category of biological products discussed for submission
Biological product shown to be highly similar to an FDA-licensed reference product; Biological product demonstrated to be highly similar to a reference product
Biological product shown to be interchangeable with a reference product
Bifurcated REMS for a biosimilar product and reference product
biological product that can be expected to produce the same clinical result as the reference product; Product that may be substituted for the reference product
typically manufactured through chemical synthesis
Stakeholders
2Assist sponsors in the nonclinical evaluation
Entities submitting supplements to BLAs
Regulatory Context
Attributes
3March 23, 2020; March 23, 2020, when NDAs are deemed to be BLAs
highly similar to the reference product notwithstanding minor differences in clinically inactive components
standard where product produces same clinical result and risk of switching is not increased
Related CFR Sections (5)
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR314.105§ 314.105 Approval of an NDA and an ANDA.
(a) FDA will approve an NDA and send the applicant an approval letter if none of the reasons in § 314.125 for refusing to approve the NDA applies. FDA will issue a tentative approval letter if an NDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but caRead full regulation →
- 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.
(a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (Status: Final)
- CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (Status: Final)
- Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers (Status: Draft)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (Status: Final)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Status: Final)