Skip to main navigation Skip to main content
Home
Menu
  • Join Our Mailing List
  • Contact Us
  • About
    • About BBCIC
      • BBCIC FAQs
    • Governance
      • Board of Managing Directors
      • Communications Committee
      • Steering Committee
      • Science Committee
    • Partners
    • Contact
  • Research
    • Approach
    • Range of Research
    • Our Research
    • Publications & Presentations
  • News & Events
    • BBCIC Calendar
    • BBCIC News
    • Quarterly Newsletters
  • Resources
    • BBCIC Resources
    • FDA Guidance
    • Biosimilars Facts
  • Search
 
Enter your keyword(s)

Breadcrumb

  1. BBCIC
  2. Resources
  3. FDA Guidance

Main navigation

  • About
    • About BBCIC
    • Governance
    • Partners
    • Contact
  • Research
  • News & Events
  • Resources
    • BBCIC Resources
    • FDA Guidance
    • Biosimilars Facts
  • Search

FDA Guidance

  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 — Updated 9/17/2021
  • Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations — Updated 8/3/2020
  • Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product — Updated 5/6/20
  • Draft Guidance for Industry on Considerations in Demonstrating Interchangeability with a Reference Product —  Updated 5/6/2020
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product — Updated 4/24/20
  • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product — Updated 2/27/2020
  • Nonproprietary Naming of Biological Products  —  Updated 11/18/2019
  • Labeling for Biosimilar Products — Updated 11/18/2019
  • Draft Guidance for Industry on Labeling for Biosimilar Products —  Updated 11/18/2019
  • Draft Guidance for Industry on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA [Biosimilar User Fee Act] Products  — Updated 10/30/2018
  • Designation of Official Names and Proper Names for Certain Biological Products —  Updated 8/28/2015
  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 —  Updated 4/30/2015
Why BBCIC?
Learn more about BBCIC and what we do.
Download Our Fact Sheet
Join BBCIC
Help us monitor use, impact, safety, and clinical effectiveness of biologics including biosimilars.
Participate in BBCIC

Contact Us

Send a Message

Address

675 N Washington Street
Suite 220
Alexandria, VA 22314

Phone

703.684.2600

Menu

  • About
  • Research
  • News & Events
  • Resources
  • Search
BBCIC Logo
  • Antitrust
  • Privacy Policy
  • Disclaimer


© 2023 Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)

  • About
    • About BBCIC
      • BBCIC FAQs
    • Governance
      • Board of Managing Directors
      • Communications Committee
      • Steering Committee
      • Science Committee
    • Partners
    • Contact
  • Research
    • Approach
    • Range of Research
    • Our Research
    • Publications & Presentations
  • News & Events
    • BBCIC Calendar
    • BBCIC News
    • Quarterly Newsletters
  • Resources
    • BBCIC Resources
    • FDA Guidance
    • Biosimilars Facts
  • Search