Description
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation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 biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act. This draft guidance document revises the draft guidance document entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act,” issued November 2020 to retain appropriate Q&As in draft.
Scope & Applicability
Product Classes
4Biological product shown to be highly similar to an FDA-licensed reference product; Biological product demonstrated to be highly similar to a reference product
The biological product to which a biosimilar is compared
A biosimilar product determined to be interchangeable with the reference product.; may be substituted for the reference product without the intervention of the prescribing health care provider
biological products shown to be biosimilar to a reference product
Stakeholders
3Prescribing professional who does not need to intervene for interchangeable substitution
Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
5Measurement of potency for biological products
specifications for the purity, strength, and composition of dietary supplements
characterizing the safety of individual drugs
The state of being interchangeable with a reference product
The state of being biosimilar to a reference product
Related CFR Sections (3)
- 21CFR601.5§ 601.5 Revocation of license.
(a) A biologics license shall be revoked upon application of the manufacturer giving notice of intention to discontinue the manufacture of all products manufactured under such license or to discontinue the manufacture of a particular product for which a license is held and waiving an opportunity forRead full regulation →
- 21CFR601.3§ 601.3 Complete response letter to the applicant.
(a) Complete response letter. The Food and Drug Administration will send the biologics license applicant or supplement applicant a complete response letter if the agency determines that it will not approve the biologics license application or supplement in its present form.Read full regulation →
- 21CFR601.4§ 601.4 Issuance and denial of license.
(a) A biologics license shall be issued upon a determination by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research that the establishment(s) and the product meet the applicable requirements established in this chapter. A biologics liceRead full regulation →