The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials. In particular, the guidance enables companies to submit batches of reference medicines that have been sourced from outside of the European Economic Area (EEA).
The changes will come into effect following the revisions of the EMA’s guidelines on similar biological medicinal products, which is expected to be released as a draft for public consultation in early 2013.
Currently, companies developing a biosimilar must use a reference product that is authorized in the EEA. All batches of the reference medicine must also be sourced from the EEA, which often requires companies to repeat all clinical studies with batches sourced from various locations. In the past, this approach had helped to ensure reliable comparability.
When the changes come into effect, companies will be responsible for performing analytical comparisons to ensure that the batches used are representative of the EEA-authorized reference medicine. Companies may also need to supply comparative pharmacokinetic and pharmacodynamic data.
The new approach to biosimilars was first announced by Commissioner John Dalli in June 2012. EMA was the first regulatory authority to establish a comprehensive framework for biosimilars in 2005. However, the development of biosimilars has become an increasingly global business, with many countries having now established biosimilars legislation similar to Europe’s. According to Dalli, these developments have allowed the European Commission to revise the interpretation of its biosimilars guidelines to accept biosimilar applications that contain clinical data with reference products not sourced from the EEA.
Because the changes of interpretation are made based on the existing legislation, it means there will not be a lengthy legislative process.