| Agency | Document Title | Available at |
| World Health Organization (WHO) | Guidelines on Evaluation of Similar Biotherapeutic Products | http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf |
| World Health Organization (WHO) | Good manufacturing Practices for Biological Products | http://www.who.int/biologicals/areas/vaccines/Annex_2_WHO_Good_manufacturing_practices_for_biological_products.pdf?ua=1 |
| EMA―European Medicines Agency | Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies?non-Clinical and Clinical Issues | http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf |
| FDA―United States Food and Drug Administration | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf |
| FDA―United States Food and Drug Administration | Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf |
| FDA―United States Food and Drug Administration | Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf |