The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product and making an application to the agency.
While FDA is still arguing the pathway and States are taking actions to restrict and control biosimilar entry in the US, EMA, the pioneer regulatory body for biosimilars and the watchdog of Europe, again released a guideline to describe the steps and improve the processes within the EU.
There are some critical changes in the new guideline. Reference products, should still be authorized in the European Economic Area but as expected, EMA now says that: “with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, it may be possible for an Applicant to compare the biosimilar in certain clinical studies and in vivo non-clinical studies (where needed) with a non-EEA authorised comparator (i.e. a non-EEA authorised version of the reference medicinal product) which will need to be authorised by a regulatory authority with similar scientific and regulatory standards as EMA (i.e. ICH countries).”
This guideline outlines the general principles to be applied for biosimilars as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.
The consultation of the draft guideline is open until the end of October 2013 and the guideline can be reached from here.