- Biosimilars Patent Exchange
- Biologics Price Competition and Innovation Act of 2009 (BPCIA)
- U.S. Food and Drug Administration (FDA) Biosimilars Webpage
- FDA Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
- FDA Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
- FDA Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
- European Medicines Agency (EMA) Biosimilars Webpage
- EMA Guideline on Similar Biological Medicinal Products
- EMA Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues
- EMA Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-clinical and Clinical Issues
- Higher Ed Association Letter to FDA_biosimilars_11 5 12_final