Biosimilars Guidances

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• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers; Draft Guidance for Industry
  CDER/CBER, July 2024

• Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry
  CDER/CBER, June 2024

• Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry
  CDER/CBER, September 2023

• Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry
  CDER/CBER, September 2023

• Classification Categories for Certain Supplements Under BsUFA III; Draft Guidance for Industry
  CDER/CBER, August 2023

• Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics; Guidance for Industry
  CDER/CBER, March 2022

• Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry
  CDER/CBER, September 2021

• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3); Draft Guidance for Industry
  CDER/CBER, September 2021

• Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act; Draft Guidance for Industry
  CDER/CBER, November 2020

• Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed; Draft Guidance for Industry
  CDER/CBER, February 2020

• Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations; Draft Guidance for Industry
  CDER/CBER,  May 2019

• Considerations in Demonstrating Interchangeability With a Reference Product; Guidance for Industry
  CDER/CBER,  May 2019

• Labeling for Biosimilar Products; Guidance for Industry
  CDER/CBER, July 2018

• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry
  CDER/CBER, December 2016

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Guidance for Industry
  CDER/CBER, April 2015

• Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; Guidance for Industry
  CDER/CBER, April 2015

• Reference Product Exclusivity for Biological Products Filed Under; Draft Guidance for Industry
  CDER/CBER, August 2014