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generic, biosimilar and value added medicines industries across Europe. use/50years/docs/50years_pharma_timeline_v3.pdf. (p.11). 6 Putrik et al. London, UK: European Medicines Agency. 2006. emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf. KFDA Activities related to Biosimilars. ? 2007.4. Discussion group was established. ? 2008.5. FDA/WHO Joint Symposium on Biosimilar. Products. ? 2009.7. Safety monitoring for all biological medicines, including biosimilars pdf. Accessed on 6 March 2017. 7. European Medicines Agency: Immunogenicity. The goal of biosimilar development is to create a biologic drug fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. The. European Medicines Agency (EMA) therefore requires evidence (via pre-clinical studies and phase I and III clinical studies) that a biosimilar medicine is5 | biosimilars handbook. Extrapolation of Indications. Quality Assurance for the Manufacture of Biopharmaceuticals. Regulation of Biosimilar Medicines.

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