The draft guideline outlines the general principles to be applied for biosimilars and describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles of establishing biosimilarity.

One interesting change proposed by the new draft guideline for biosimilars is that EMA will accept the use of a non-EEA authorized comparator or reference product. EMA has made this change ‘with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials’. The caveat is that the product ‘will need to be authorised by a regulatory authority with similar scientific and regulatory standards as EMA’.

The proposed draft guideline will replace the guideline on Similar Biological Medicinal Products (CHMP/437/04). EMA is seeking stakeholders’ views on the draft guideline, which is available on the EMA website.

Draft guideline on similar biological medicinal products
Date: 2 May 2013
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf

Feedback on the draft guideline can be submitted to: BMWPSecretariat@ema.europa.eu until the end of October 2013. EMA did not state, however, when it expects the final guideline, which will replace CHMP/437/04, to be ready.

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