Formycon Starts Clinical Development for FYB206, a Keytruda Biosimilar

Formycon AG has announced the initiation of its clinical development program for FYB206, a biosimilar candidate targeting the immuno-oncology blockbuster drug Keytruda® / pembrolizumab. The program began with the inclusion of the first patient in a Phase I clinical trial named "Dahlia."

The "Dahlia" trial focuses on comparing the pharmacokinetics, safety, and tolerability of FYB206 with Keytruda® in patients who have had a malignant melanoma completely surgically removed. Additionally, a parallel Phase III trial, "Lotus," will soon commence to evaluate the safety and efficacy of FYB206 in patients with non-small cell lung cancer.

Dr. Stefan Glombitza, CEO of Formycon AG, highlighted the significance of this milestone, emphasizing the therapeutic and commercial potential of FYB206. Chief Scientific Officer Dr. Andreas Seidl noted the sophisticated study design, developed in collaboration with the FDA and EMA, which aims to ensure precise pharmacokinetic measurements.

Keytruda® is currently the best-selling drug worldwide, with 2023 sales reaching USD 25 billion. As Formycon advances its clinical trials, the company anticipates market entry for FYB206 post-2029 and 2030, upon the expiration of Keytruda®'s market exclusivity in the USA and EU, respectively.