Drugs

Biosimilars

Below is a sortable listing of Biosimilarity Guidances.

CategoryTitleTypeDate
Biosimilarity; Procedural Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 306KB) Final Guidance 11/17/15
Biosimilarity Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF - 169KB) Final Guidance 04/28/15
Biosimilarity Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (PDF - 144KB) Final Guidance 04/28/15
Biosimilarity Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF - 150KB) Final Guidance 12/28/16
Procedural; Biosimilarity Reference Product Exclusivity for Biological Products Filed Under (PDF - 99KB) Draft Guidance 08/04/14
Biosimilarity Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (PDF - 104KB) Draft Guidance 05/12/15
Biosimilars Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry (PDF - 107KB) Final Guidance 04/28/15
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF - 229KB) Draft Guidance 01/17/17
Biosimilars Statistical Approaches to Evaluate Analytical Similarity (PDF - 125KB) Draft Guidance 09/21/17

Page Last Updated: 09/21/2017
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