The European Medicines Agency (EMA) has updated its guidance for drugmakers on biosimilar medicines to reflect the European Commission’s confirmation that, in future, it intends to accept batches of reference medicines sourced from outside the European Economic Area (EEA).
Proposals for the move, which seeks to speed the global development of biosimilars and avoid unnecessary repetition of clinical trials, were first revealed by John Dalli, the European Commissioner for Health and Consumer Policy, in June.
Speaking at the annual conference of the European Generic medicines Association (EGA), the Commissioner had reminded delegates that, in 2005, the European Union (EU) had been the first agency in the world to set up a comprehensive regulatory framework for biosimilars, and that this had been followed by many others.
“This may have contributed to the fact that the EU is also a leading industrial base for the development of biosimilars,” he said, but also noted that that the development of such products has become an increasingly global business.
Up to now, the authorisation of biosimilars in the EU has been based on comparison of a product with a reference product authorised in the EU, said Commissioner Dalli, and, while “we have consistently interpreted our legislation in a way that requires data provided in the marketing authorisation dossier to be established with batches sourced in the EU…I recognise that such an interpretation requires applicants to repeat all clinical studies with batches sourced from various continents.”
So, following a reconsideration of the EU approach, there has been a revision, under which it will be accepted that a biosimilar application contains clinical data with reference products that are not sourced from the EU. Moreover, this change of interpretation is possible on the basis of existing legislation, which means it can be applied without awaiting “a lengthy legislative process,” he said.
Therefore, the EMA says that it will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies.
Applicants will be responsible for establishing that such batches are “representative of the reference medicine authorised in the EEA through an extensive analytical comparison. Applicants may need to supply comparative pharmacokinetic and pharmacodynamic data to ascertain the suitably of batches of the reference medicines,” says the Agency.
These changes will come into effect after the revision of the EMA Guideline on Similar Biological Medicinal Products, for which the Agency expects to release a draft version for public consultation in early 2013.
