Description
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
Scope & Applicability
Product Classes
5Biological product shown to be highly similar to an FDA-licensed reference product; Biological product demonstrated to be highly similar to a reference product
Biosimilar product determined to be interchangeable with the reference product
ADC: antibody-drug conjugate
biological products shown to be biosimilar to a reference product
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
9Field B.2.2.2 describing the physical form of the VMP
controls in place to maintain the strength, composition, and purity
Should be comparable to those used in previous trials
Trigger for PREA requirements
Nature, location, and levels of sugar chains
Terms in which there must be no clinically meaningful differences; Standards required to be demonstrated for biological product licensure
characterizing the safety of individual drugs
specifications for the purity, strength, and composition of dietary supplements
Measurement of potency for biological products
Related CFR Sections (4)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR312.10§ 312.10 Waivers.
(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (Status: Final)
- Prussian Blue Drug Products — Submitting a New Drug Application (Status: Final)
- Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (Status: Final)
- Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (Status: Final)
- Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff (Status: Final)
- Tropical Disease Priority Review Vouchers (Status: Final)
- Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry (Status: Draft)
- Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry (Status: Final)