In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a reference biological medicinal product authorised in the EU.

To obtain a marketing authorisation for a biosimilar, applicants need to submit evidence substantiating similarity with the reference biological medicinal product, in terms of quality characteristics, biological activity, safety and efficacy.

The existing EMA scientific advice procedure can advise developers of biosimilars on the appropriate comparability tests and studies they need to conduct to support their marketing authorisation application. The procedure does not, however, allow for a formal assessment of data already available to developers.

As part of the pilot project, the EMA’s Scientific Advice Working Party (SAWP) will provide an in-depth review of the data already available to developers that are related to the comparability between the biosimilar and the reference biological medicinal product. Depending on the data already available, developers will receive tailored advice concerning the studies and tests that should be carried out in the next steps of the biosimilar development.

Like the existing EMA scientific advice, the tailored scientific advice will not constitute a formal pre-assessment of the data that will be submitted with the marketing authorisation application for the biosimilar.

The tailored scientific advice procedure

Developers should submit a Letter of Intent and a briefing package following the time line for the standard EMA scientific advice procedure. The briefing package must include:

• an overview of the full development plan of the biosimilar;
• the available quality, analytical and functional data, directly related to the comparability between the biosimilar and the reference biological medicinal product;
• questions related to the next development steps.

Developers taking advantage of the tailored scientific advice procedure will have a pre-submission meeting during which the suitability of their data package is reviewed. The data submitted by the developer should be appropriate and mature enough in view of the specific questions submitted to the SAWP.SAWP will require an extra month in addition to the standard EMA scientific advice procedure timelines to review the quality data and the questions accepted in the pilot. The pilot is planned to run until six scientific advice requests have been completed. Maximum one scientific advice request will be accepted per month.

Timeline

On the basis of the data available, the SAWP will provide its advice concerning the next quality steps, non-clinical, or clinical steps in development.

Questions concerning quality issues unrelated to the comparability between a biosimilar and the reference biological medicinal product fall outside the scope of the pilot project. These questions can be submitted separately using the existing EMA scientific advice procedure.

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