EMA to Launch Tailored Biosimilar Scientific Advice Pilot

Regulatory NewsRegulatory News | 16 December 2016 |  By 

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.

The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard scientific advice does not include the assessment of existing data).

EMA plans to run the pilot until it has completed six scientific advice requests, with maximum of one scientific advice request accepted per month. The agency will analyze the outcome of the pilot after its completion.

Pilot Details

The pilot will be open to all types of biosimilars and includes a pre-submission meeting to review the suitability of the data package. EMA also says that applicants should note that the agency’s Scientific Advice Working Party will need an extra month in addition to normal scientific advice timelines to review applications for the pilot.

In terms of what should be submitted, applicants are expected to provide an overview of the full development plan and include questions not only related to the quality development but also to the proposed non-clinical and/or clinical development, thus allowing EMA’s Committee for Medicinal Products for Human Use (CHMP) to provide appropriate advice on the next steps of the development (quality, non-clinical, clinical) based on the quality data available.

But EMA notes that questions on quality issues unrelated to the comparability between the biosimilar and reference product are outside the scope of the pilot and can be submitted separately using the normal scientific advice procedure.

For any information regarding the pilot please contact ScientificAdvice@ema.europa.eu.

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


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