On Wednesday, Formycon AG announced that their pembrolizumab biosimilar candidate, FYB206, demonstrated high structural and functional similarity to the reference product Keytruda® in a comparative analytical evaluation. Published in the peer-reviewed journal Drugs in R&D, the findings bolster the case for advancing FYB206 into clinical trials.
The evaluation was meticulously designed to compare clinically relevant quality attributes between Keytruda® and FYB206. The analytical panel relied on existing pembrolizumab data and initial analysis of Keytruda® to assess various characteristics, including structural characterization, glycosylation, and biological function. Crucial functional attributes that could affect clinical performance, like PD-1 binding and neutralization, were found to be highly similar in FYB206.
Summarizing the data from the assessments, the similarity between FYB206 and Keytruda® was confirmed across multiple parameters such as structure, purity, and potency. This comprehensive data package lays a strong foundation for the biosimilar's clinical trials.
Dr. Andreas Seidl, the Chief Scientific Officer at Formycon, expressed optimism about the results, stating, "The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda®." He emphasized the company's commitment to initiating new clinical centers and working with investigators to meet the needs of patients with high unmet medical demands.
The active ingredient in both FYB206 and Keytruda®, pembrolizumab, is a humanized monoclonal antibody used in cancer treatment. By blocking the PD-1 and PD-L1 interaction, it activates the immune system's response against tumor cells. Keytruda® is a leading drug with sales potentially reaching $30 billion by 2026 due to its wide oncological applications and global demand.
FYB206 is currently undergoing a pharmacokinetic equivalence trial named "Dahlia" and a trial called "Lotus" to assess its efficacy and safety in comparison to Keytruda® for treating malignant melanoma and non-small cell lung cancer, respectively.
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