EMA asks for comments on revised biosimilars guideline
Revision intends to clarify terminology and safety and efficacy of biosimilars
The European Medicines Agency (EMA) has published a new biosimilars draft guideline for consultation, which outlines the general principles that the industry must take into account when developing an application to the Agency.
The publication of the initial guideline on biosimilars in September 2005 established a regulatory framework that has led to the approval of 14 biosimilars in the European Union (EU) to date. Five applications for biosimilars are currently under review.
On the basis of the experience gained since the publication of the initial guideline, the EMA said the revision ‘intends to provide clarification with regards to terminology for biosimilars; give better clarity on the principles of biosimilarity, including on safety and efficacy aspects; and clarify requirements regarding the posology, route of administration and formulation of biosimilars’.
The revision also covers global development aspects, including the choice of the reference product when conducting non-clinical and clinical studies.
In order to receive marketing authorisation for a biosimilar in the EU, developers 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 authorised in the European Economic Area (EEA), the EMA said.
With the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, the guidance says it may be possible for an applicant to compare its biosimilar in certain clinical studies and in vivo non-clinical studies with a comparator authorised outside the EEA. This comparator would 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 authorised in the EEA.
The revised guideline is open for consultation until 31 October.
