Munich – Formycon AG, a leading independent developer of biosimilar drugs, has received a scientific advice letter from the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development program for FYB201, the first biosimilar product candidate to emerge from its development pipeline, following the receipt of similarly favorable scientific advice from the European Medicines Agency (EMA) in December 2014. In its letter, the FDA, like the EMA, expresses its support for the company’s proposed approach to proceed with FYB201 directly to the pivotal phase III clinical trial. Based upon the scientific advices received from the EMA and FDA, Formycon and its license partner Bioeq GmbH are now in a position to carry forward with a clinical study design for a global phase III trial which will enable them to apply simultaneously for regulatory approval in both the U.S. and European Union. All preclinical activities and the preparations for the phase III trial for FYB201 are moving forward according to plan.
The market launch of FYB201 in the highly regulated markets, particularly the U.S. and European Union, is planned to begin starting from 2020.