European Medicines Agency comparability guidelines

European Medicines Agency—Committee for Proprietary Medicinal Products. Guideline on the Comparability of Medicinal Products Containing Biotechnology-... 

Combe C, Tredree RL, Schellekens H Biosimilar epoetins an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy (2005) 25(7) 954—962. 

The features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... 

Committee for Proprietary Medicinal Products Guideline on Comparability of Medicinal Products Containing Biotech-nology-derived Proteins as Active Substance. Non-clinical and Clinical Issues. Evaluation of Medicines for Human Use, The European Agency for the Evaluation ofMedicinal Products, London (2003). 

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