Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues - Scientific guideline

This document outlines the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It covers manufacturing processes, the comparability exercise for quality, considering the choice of reference product, analytical methods, physicochemical characterisation, biological activity, purity and specifications of the similar biological medicinal product.

Keywords: Similar biological medicinal product, biosimilar, recombinant proteins, quality, biosimilar comparability exercise, biosimilarity, reference medicinal product

Document history - Revision 1 (current version)


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