EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

This guideline lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It addresses the requirements regarding manufacturing processes, the comparability exercise for quality, considering the choice of reference medicinal product, analytical methods, physicochemical characterisation, biological activity, purity and quality attributes for relevant specifications of the similar biological medicinal product.