EMA Revises Draft Guideline on Biosimilars

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EMA clarifies biosimilars guidelines.

The European Medicines Agency (EMA) has invited comments on its revised guideline on similar biological medicines. The draft guideline document outlines the concept and general principals of biosimilars. Public consultation on the draft revised guideline is open until October 31, 2013.

EMA’s first biosimilars guideline was published in September 2005 and established a regulatory framework that has led to the approval of 14 biosimilars in the European Union (EU) to date. EMA has revised the guideline to provide clarification on terminology, biosimilarity principles including safety and efficacy, and requirements regarding the posology, route of administration, and formulation. The revision also discusses the choice of reference product when conducting non-clinical and clinical studies.


In the EU, developers of biosimilars need to conduct comparability studies to show the similar nature, in terms of quality, safety, and efficacy, of the biosimilar and the chosen reference medicinal product authorized in the European Economic Area (EEA). The revised guideline explains that it may be possible for an applicant to compare its biosimilar in certain clinical studies and in vivo non-clinical studies with a comparator authorized outside of the EEA. This comparator will need to be authorised by a regulatory authority with similar scientific and regulatory standards to those of the EMA. It will then be the applicant's responsibility to establish that the comparator is representative of the reference product authorized in the EEA.