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| Procedural; Biosimilarity | Reference Product Exclusivity for Biological Products Filed Under (PDF – 99KB) | Draft Guidance | 08/04/14 |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| Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF – 142KB) | Draft Guidance | 05/13/14 |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Procedural | Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF – 272KB) | Draft Guidance | 03/29/13 |
| Biosimilarity | Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 | Draft Guidance Updated for 508 compliance.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| Biosimilarity | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF – 576KB) | Draft Guidance | 02/09/12 |
| Biosimilarity | Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF – 432KB) | Draft Guidance | 02/09/12 |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