Drugs

Biosimilarity

Below is a sortable listing of Biosimilarity Guidances.

Category	Title	Type	Date
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Procedural	Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 272KB)	Draft Guidance	03/29/13
Biosimilarity	Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009	Draft Guidance Updated for 508 on 3/22/12.	02/09/12
Biosimilarity	Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF - 576KB)	Draft Guidance	02/09/12
Biosimilarity	Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF - 432KB)	Draft Guidance	02/09/12