TY - STD TI - GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs). [http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf] UR - http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf ID - ref1 ER - TY - CHAP PY - 2005 DA - 2005// BT - Guideline on similar biological medicinal products PB - London CY - European Medicine Evaluation Agency ID - ref2 ER - TY - CHAP PY - 2006 DA - 2006// BT - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues PB - London CY - European Medicine Evaluation Agency ID - ref3 ER - TY - CHAP PY - 2006 DA - 2006// BT - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: nonclinical and clinical issues PB - London CY - European Medicine Evaluation Agency ID - ref4 ER - TY - STD TI - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf] UR - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf ID - ref5 ER - TY - STD TI - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product. [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf] UR - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf ID - ref6 ER - TY - STD TI - The Provisions for Drug Registration (SFDA Order 28). 2007, [http://www.sfda.gov.cn/WS01/CL0053/24529.html] UR - http://www.sfda.gov.cn/WS01/CL0053/24529.html ID - ref7 ER -