Formycon Reports Positive Clinical Data for Keytruda® Biosimilar FYB206

Formycon AG has announced positive results from its pivotal Dahlia pharmacokinetic (PK) study, demonstrating the bioequivalence of its biosimilar candidate FYB206 to the oncology drug Keytruda®. This marks a significant milestone in Formycon’s development efforts, highlighting its strong position among pembrolizumab biosimilar developers.

The company conducted a randomized, double-blind, multicenter study to establish the pharmacokinetic equivalence of FYB206 and Keytruda®. Following this success, Formycon is preparing for regulatory submissions, aiming to expedite the availability of FYB206 globally after Keytruda®’s exclusivity period ends.

Formycon had previously aligned with the FDA on a streamlined strategy to demonstrate therapeutic comparability, focusing now on finalizing regulatory dossiers. FYB206 is targeted to enhance global access to pembrolizumab, an immune checkpoint inhibitor used for treating various cancers.