This document describes the concept of similar biological medicines (also known as ‘biosimilars’) and outlines the general principles to be applied.
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 release of the initial guideline, 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;
• 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 get a marketing authorisation 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 authorised in the European Economic Area (EEA).
With the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, the 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 authorised 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 authorised in the EEA.