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Priority review Guidance Amended Draft

FDA Draft Q&As on Biosimilar Development and BPCI Act

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Detected March 10th, 2026
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Summary

The FDA has issued a draft guidance document providing updated answers to common questions regarding biosimilar development and the Biologics Price Competition and Innovation Act (BPCI Act). This revision replaces a previous draft and focuses on specific Q&As related to the abbreviated licensure pathway for biological products.

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What changed

The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have released a revised draft guidance document (Docket Number: FDA-2011-D-0611) that updates previous Q&As concerning biosimilar development under the Biologics Price Competition and Innovation Act (BPCI Act). This revision specifically amends Q&As I.8, I.10, and I.19, which were previously withdrawn from a final guidance issued in September 2021. The guidance aims to clarify the abbreviated licensure pathway for biological products and facilitate the development of biosimilar and interchangeable biosimilar products.

This draft guidance is intended to inform prospective applicants and other stakeholders involved in biosimilar development. While comments can be submitted at any time, the FDA encourages interested parties to review the revisions and provide feedback. The document does not impose new mandatory requirements but offers clarification on existing statutory interpretations. Regulated entities should review the updated Q&As to ensure their development strategies align with the FDA's current understanding of the BPCI Act requirements.

What to do next

  1. Review revised draft guidance on biosimilar development and BPCI Act.
  2. Submit comments to Docket Number FDA-2011-D-0611 if revisions impact development strategies.

Source document (simplified)

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Guidance Documents

Docket Number: FDA-2011-D-0611 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation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 and interchangeable biosimilar products, as well as describe FDA’s interpretation of certain statutory requirements related to the abbreviated licensure pathway for biological products added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance revises and replaces the draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)” issued September 17, 2021 to provide certain revisions to Q&As I.8, I.10, and I.19, which have been withdrawn from the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act” issued September 20, 2021.

Submit Comments

Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0611.

  • ## Content current as of:

03/09/2026

  • Regulated Product(s)

    • Drugs

Topic(s)

  • Biosimilars

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Source

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Classification

Agency
Food and Drug Administration
Instrument
Guidance
Legal weight
Non-binding
Stage
Draft
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Geographic scope
National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Legal
Topics
Biosimilars Drug Development

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Federal Courts 26 State Courts 91 Securities Regulation 6 Financial Regulation 43 Consumer Protection 5 Drug Safety 45 Data Protection 21 Competition 2 Attorneys General 3 Insurance Regulation 5 Trade & Export 36 Legislation 42 Energy Regulation 13 Environment 3 Labor & Employment 2 Tax 1

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