EMA Launching Pilot to Support Biosimilars Development

The European Union’s European Medicines Agency (EMA) is launching a tailored scientific advice pilot project in February 2017 to support step-by-step development of new biosimilars.

The procedure will advise biosimilar developers on the studies they should conduct, based on a review of the quality, analytical, and functional data they already have available. Standard advice does not include the assessment of existing data, the EMA states.

The pilot is expected to run until it has completed six scientific advice requests, with a maximum of one scientific advice request accepted per month. The program is available to all types of biosimilars, and includes a pre-submission meeting to review the suitability of the data package. The EMA advises biosimilar developers that the data package to be reviewed should be mature in order to fully benefit from the pilot. Data submitted should be directly related to the comparability exercise between the biosimilar and the reference medicinal product and statistical methods used for the comparison of quality data should be presented.

Applicants for the project should provide an overview of the full development plan and include questions related to quality development as well as questions related to the proposed nonclinical and/or clinical development so that the EMA’s Committee for Medicinal Products for Human Use (CHMP) can provide appropriate advice on the next steps of the development based on the quality data available.

The EMA’s Scientific Advice Working Party requires an extra month in addition to normal scientific advice timelines to review applications. A maximum of one Scientific Advice per month can be accepted.

Click here for a link to the EMA’s website showing an up-to-date list of the biosimilars approved in the EU.