Since the original biosimilars guideline came into effect in June 2006 several biosimilar products have come onto the EU market, and the number of scientific advices given by EMA’s Committee for Human Medicinal Products on the development of biosimilar products has increased significantly and the regulatory framework is becoming wider, e.g. the draft guideline of the biosimilar monoclonal antibodies is being finalised.

Therefore, due to the development of more complex biosimilars, EMA has proposed a list of several topics for re-evaluation. These include selection of relevant species for non-clinical studies, need for clinical equivalence studies and other issues of the design of pivotal clinical studies, role of biomarkers, amount of immunogenicity data needed and the possibility to extrapolate to other indications.

EMA invites feedback on plans to revise existing guidelines on biosimilar medicines.

The concept paper seeks stakeholders’ views on the need to revise the 2006 'guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues'. This concept paper is available from: www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500115611&murl=menus/document_library/document_library.jsp&mid=WC0b01ac058009a3dc&jsenabled=true

Feedback for the concept paper can be submitted until the end of December 2011. Once all feedback has been reviewed, EMA will start the revision of the guidelines as appropriate. EMA expects a draft revised guideline to be released in the first quarter of 2012.

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