Formycon updates on development of biosimilars

Germany’s Formycon (ETR: FYB) has decided today to prematurely terminate the Phase III trial (Lotus) for its biosimilar candidate FYB206.

Based on an intensive scientific dialogue with the Food and Drug Administration (FDA), the executive board, after careful consideration, has concluded that the continuation of the study is no longer necessary for the development and approval of FYB206 in the USA.

The therapeutic comparability of FYB206 with the reference drug, Merck & Co’s (NYSE: MRK) mega blockbuster Keytruda (pembrolizumab) can be sufficiently demonstrated using data from the ongoing parallel study in the melanoma indication (Dahlia), combined with a comprehensive analytical program. According to preliminary estimates, discontinuing the Phase III trial could lead to investment savings in the high double-digit million range over the next few years, positively impacting the company’s cash flow statement and liquidity, Formycon explained.