1. IFPMA points to consider in the drafting of WHO guidelines for biosimilar medicinal products, issued on November 22, 2007, http://www.ifpma.org/fileadmin/templates/ifpmaissues/pdfs/IFPMA_Pts_to_Consider_for_WHO_Biosimilar_GLs_Nov_2007.pdf.
2. Guidelines on evaluation of Similar Biotherapeutic Products (SBPs). EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 19 to 23 October 2009. Adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization; 19–23 October 2009.
3. Guideline On The Choice Of The Non-INFERIORITY MARGIN. EMEA/CPMP/EWP/2158/99 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE; 27 July 2005.
4. Guidance for Industry: Non-Inferiority Clinical Trials. DRAFT GUIDANCE. March 2010. Available at: Food and Drug Administration, Dockets home page, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf.