EMA will accept reference meds made outside Europe under biosimilars guidelines
Under current legislation firms working on biosimilar development in Europe are required to use batches of EEA approved and sourced drugs as reference medicines.
However, the European Medicine Agency’s (EMA) now says it will accept batches of reference medicines from outside the EEA for “certain pre-clinical and clinical studies in the comparability exercise.”
The changes – which the agency hopes will drive biosimilar developments, as well as avoiding unnecessary trial repetition – will come into effect as part of the revision of current guidelines on similar biological medicinal products.
A draft version of the revisions is expected to be released for public consultation in early 2013.
More work?
According to a statement from the EMA, the move could mean more work for those applicants who do wish to source their reference medicines externally.
The health body said that developers using non-EEA products would be be responsible for establishing batches are representative of the reference medicine authorised in Europe “through an extensive analytical comparison.”
“Applicants may need to supply comparative pharmacokinetic and pharmacodynamic data to ascertain the suitability of batches of the reference medicines,” the statement also said.
However in European Commissioner for Health and Consumer Policy John Dalli’s speech this July, he said the move was necessary to keep pace with other continents.
“Biosimilars have a very promising potential as they provide more affordable access to highly-innovative biological medicines,” he said.
“What we have seen in the recent past, is that the development of biosimilars has become an increasingly global business. I realise however that the application of the EU rules do not fully match this trend.”
