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It has been a long established idea that, since the European Union (EU) approval of the first biosmilar way back in 2006, progress in this area has been more troublesome than first anticipated. To date, there have only been 26 biosimiliar approvals, and an often erratic approach to acceptance and substitution within the individual member states once a biosimilar becomes available.
To help push forward the regulatory landscape in this arena, the European Medicines Agency (EMA) is launching a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. This new initiative by the agency aims to provide developers of biosimilars with advice on the studies and tests that they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.
This approach is expected to better support the stepwise development of biosimilars that is recommended in 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. Currently, to obtain a marketing authorisation for a biosimilar, 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 current standard scientific advice procedure that is available 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, the EMA is proposing to undertake an in-depth review of the quality, analytical and functional data available. 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. This new pathway should, if used correctly, help identify the key risk areas in the development plan as well as the regulatory strategy.
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. The 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 a maximum of one scientific advice request accepted per month. After the completion of the pilot, the EMA will carry out an analysis of the outcome.
ELC Group has a strong proven track record in the development and approval of biosimilars and have links to the major stakeholders in relation to any new regulations or proposals. We are well placed to assist clients in making the most of such pilot schemes and/or upcoming regulations.