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Executive Summary

Quality data will be focus of ‘extra advice’ offered by European Medicines Agency’s pilot, which will suggest directions for sponsors’ next steps but stop short of formal data evaluation.


The European Medicines Agency will start offering tailored scientific advice for a limited number of biosimilars as part of a pilot to be launched in February next year.

The pilot has been devised in response to a demand from companies who are looking "for this extra advice, specifically for biosimilars," the EMA told the Pink Sheet. The US Food and Drug Administration already offers biosimilar sponsors a similar possibility. (Also see "Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan" - Pink Sheet, 28 Sep, 2016.)

The EMA pilot will specifically deal with scientific advice relating to quality aspects. According to the agency, companies will be able to provide quality data and get extended advice that will help them plan future product development and prepare better for a marketing authorization submission.

EMA does not see this as advanced data assessment, as companies will only get additional advice to help them better plan their product's continuing development for next steps, such as those pertaining to quality, non-clinical, clinical aspects, the spokesperson added.

The tailored approach will be different from the EMA's current scientific advice procedure, as this does not involve a formal assessment of data. Under the tailored approach, advice will be given on the basis of the data submitted by companies. Specifically, the EMA will carry out an in-depth review of the quality, analytical and functional data available, which will allow for more tailored recommendations on the studies/tests that should be carried out in the next step of the development. This will allow companies to make a more informed decision on their development strategy once sufficient quality data has been accumulated.


Resource Intensive

Providing such tailored scientific advice will be resource intensive for the assessors and members of the EMA's scientific advice working party (SAWP). "This pilot should help us to judge how much additional effort is required and where,” the agency spokesperson said.

The fee will be the standard fee for a scientific advice procedure including quality, non-clinical and clinical questions.

To ensure that the agency is not overburdened with requests, the pilot is planned to run until six scientific advice requests have been completed, with no more than one scientific advice request accepted per month. The pilot will help the agency test the added value and feasibility of providing such a service on a permanent basis in the future. "We would explore the experience of both parties (industry and regulators) before deciding to continue/modify/not use the approach," the EMA spokesperson said.

The pilot will be open to all companies seeking scientific advice for the development of any type of biosimilar. Companies wanting to participate in the pilot will have a pre-submission meeting, during which the suitability of their data package will be reviewed. The SAWP will need an extra month on top of the normal scientific advice timelines to review the requests accepted in the pilot.

The EMA currently has 17 biosimilar products under evaluation. (Also see "Blockbuster Competitors Figure Large Among Biosimilars Under Review in EU" - Pink Sheet, 21 Dec, 2016.)

From the editors of Scrip Regulatory Affairs. 


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