Tailored scientific advice to support step-by-step development of new biosimilars

EMAThe European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

This is expected to better support the stepwise development of biosimilars that is recommended in European Union (EU) guidelines. According to this approach, the extent and nature of the studies/tests required depend on the level and robustness of data already accumulated.

Biosimilars are biological medicines developed to be highly similar to another biological medicine (also known as the reference medicine) already authorised in the EU. To obtain a marketing authorisation, developers need to establish similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise.

The standard scientific advice procedure can advise applicants on the proposed biosimilar development strategy, however it does not allow for a formal assessment of data. As part of this pilot, an in-depth review of the quality, analytical and functional data available will be carried out. Advice will be given on the basis of the data submitted allowing for more tailored recommendations on the studies/tests that should be carried out in the next step of the development. This will allow applicants to make a more informed decision on the development strategy once sufficient quality data has been accumulated. However this will not constitute a formal pre-assessment of the data submitted during the marketing authorisation application.

The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine. Any type of biosimilar will be accepted in the pilot. Companies wishing to take part in the pilot will have a pre-submission meeting during which the suitability of the data package is reviewed. EMA’s Scientific Advice Working Party (SAWP) will need an extra month in addition to normal scientific advice timelines to review the requests accepted in the pilot.

The pilot is planned to run until six scientific advice requests have been completed, with maximum one scientific advice request accepted per month.

After the completion of the pilot, EMA will carry out an analysis of the outcome.

Scientific advice is one of the Agency's main tools to facilitate the development and availability of high-quality, effective and safe medicines, for the benefit of patients. The SAWP gives scientific advice to developers of medicines to guide them on the appropriate tests and studies needed to collect robust data in support of their marketing authorisation application.

Scientific advice provided to developers is separate from the assessment of a marketing authorisation application which takes place later and does not pre-empt the recommendation from the Committee for Medicinal Products for Human Use (CHMP) on whether or not the medicine can be authorised.