EMA initiates consultation on guideline on biosimilars containing biotechnology-derived proteins

10 June 2013

The European Medicines Agency today (June 10) released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation. The document lays down the non-clinical and clinical requirements for marketing authorization of a biosimilar claiming to be similar to a biological product already marketed.

This guideline updates the previous guidance, which came into effect in 2006. Since then, the EMA notes, 14 biosimilar medicines have received marketing authorization in the European Union and the number of scientific-advice requests received by the Committee for Medicinal Products for Human Use (CHMP) on the development of biosimilar medicines has increased significantly.

On the basis of the experience gained since the release of the initial guideline, the revision provides additional guidance on the following topics:

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