Formycon AG announced the publication of results from a comparative analytical evaluation of its proposed pembrolizumab biosimilar, FYB206, and the reference product Keytruda, in the peer-reviewed journal Drugs in R&D. The study indicates that FYB206 is structurally and functionally highly similar to Keytruda, supporting its further development in clinical trials.
Analytical Similarity Assessment
The comprehensive analytical assessment was designed to demonstrate similarity in clinically relevant quality attributes between FYB206 and Keytruda. The evaluation included a wide range of analytical and functional tests categorized as structural characterization, product-related variants, glycosylation, general properties, and biological function. All tested functional attributes with a potential impact on clinical performance, such as PD-1 binding, neutralization of PD-1, and FcRn binding, were found to be highly similar to the reference product.
Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, stated, "The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda. With this solid foundation, obtained prior to the start of the pharmacokinetic equivalence and confirmatory efficacy and safety trials with FYB206 in June and July 2024, we are committed to continuously initiate new clinical centres and to work closely with the investigators to expand access for patients with high unmet medical needs."
Clinical Development
FYB206 is currently being evaluated in the "Dahlia" trial, a pharmacokinetic equivalence study comparing the pharmacokinetics, safety, and tolerability of FYB206 with Keytruda in patients receiving adjuvant treatment for malignant melanoma. The parallel "Lotus" trial is comparing the efficacy and safety of FYB206 with Keytruda in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).
Pembrolizumab and Immuno-Oncology
Pembrolizumab, the active ingredient in Keytruda, is a humanized monoclonal antibody that belongs to the class of immune checkpoint inhibitors. It is used to treat a variety of tumors by binding to the PD-1 receptor and blocking its interaction with PD-L1, thereby activating the body’s own anti-tumor immune response. Global sales of Keytruda are projected to reach USD 30 billion by 2026.
