The European Medicines Agency (EMA) announced on 16 December 2016 that it is planning to provide sponsors with tailored scientific advice on the development of biosimilars as part of a pilot programme that will be launched in February 2017.

Specifically, the pilot will offer biosimilar developers advice on the studies and tests they should conduct, based on the available quality, analytical and functional data for the medicine. EMA expects this approach to better support the stepwise development of biosimilars, as recommended in European Union (EU) guidelines [1].

The scientific advice available currently from EMA can advise applicants on the proposed biosimilar development strategy, but does not allow for a formal assessment of data. During the pilot, an in-depth assessment of the quality, analytical and functional data will be carried out. This will enable more tailored recommendations on the studies/tests that should be carried out in the next step of the development to be given. The agency does point out, however, that ‘this will not constitute a formal pre-assessment of the data submitted during the marketing authorisation application’.

Applicants wishing to take part in the pilot must submit a briefing package and take part in a pre-submission meeting during which the suitability of the data package will be reviewed. The agency also notes that companies taking part in the pilot should count on an extra month for review in addition to normal scientific advice timelines.

EMA plans to run the pilot until six scientific advice requests have been completed, with a maximum of one scientific advice request accepted per month. The agency will then analyse the outcome of the pilot and presumably make a decision on whether to continue with this kind of advice.

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Reference
1.    GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 3]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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