References
- U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Rockville, MD: FDA; 2012.
- European Medicines Agency. Guideline on Similar Biological Medicinal Products (Revision). CHMP/437/04 Rev 1. London: European Medicines Agency; 2014.
- World Health Organization Expert Committee on Biological Standardization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBP). Geneva, Switzerland: WHO; 2009.