The United States Food and Drug Administration

 Below is a list of Biosimilarity Guidances.

Category Title Type Date
Procedural; Biosimilarity Reference Product Exclusivity for Biological Products Filed Under (PDF – 99KB) Draft Guidance 08/04/14
Biosimilarity Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF – 142KB) Draft Guidance 05/13/14
Biosimilarity; Procedural Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF – 272KB) Draft Guidance 03/29/13
Biosimilarity Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 Draft Guidance Updated for 508 compliance. 02/09/12
Biosimilarity Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF – 576KB) Draft Guidance 02/09/12
Biosimilarity Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF – 432KB) Draft Guidance 02/09/12