Munich – Formycon AG, the biosimilar drug development company, is planning to begin the pivotal phase III study of clinical testing for its first biosimilar product (FYB201) already in the third quarter of 2015. The company has brought its schedule forward on the basis of preliminary guidance received from the European Medicines Agency (EMA) in London, with which Formycon is working closely to define the regulatory approval pathway and design of phase III clinical studies for FYB201. The company expects to receive the EMA’s final position as to its scientific advice in December. This is a service through which the EMA provides consultation and recommendations to drug developers on study design and clinical trials reflecting the consensus of the EMA’s scientific experts, in order to facilitate subsequent regulatory approval.

For Formycon AG, the favorable response to its proposed plan for clinical studies means a significant shortening of its development and approval schedule. “This puts us almost exactly one year ahead. The opportunity to jump directly to phase III serves as further confirmation of the high quality of our work,” says Dr. Carsten Brockmeyer, CEO of Formycon AG.

Following the company’s successful capital raising and its partnership deal for its first biosimilar drug signed with Santo Holding in 2013, this marks yet another key milestone for Formycon. Marketing launch for FYB201 in the USA and European Union is planned starting in 2020 – and in certain selected countries should be possible starting already in 2018. The two other biosimilar drugs currently in Formycon’s development pipeline continue to move forward according to plan and remain the subject of discussions with various pharmaceutical and generic companies.