Pharmacology Daily Report: 01/25/2024

A Phase I randomized study investigated the effect of the proposed biosimilar denosumab GP2411 in 492 healthy males and found that GP2411 demonstrated pharmacokinetic and pharmacodynamic similarity to reference denosumab with fully contained 90% confidence intervals for AUC(inf), AUC(last), and C(max) within the prespecified equivalence margins (1). The occurrence of treatment-emergent adverse events was similar across GP2411, EU-Xgeva®, and US-Xgeva® with most being Grade 1 or 2 and less than 30% treatment-related. Rates of positive anti-drug antibodies were similar and mostly transient. This study supports the continued development of GP2411 as a biosimilar to denosumab. The trial was registered at EudraCT 2019-001651-39.

Reference

Vogg B, Poetzl J, El Galta R, Fuhr R, Schwebig A, Sekhar S. Pharmacokinetics and pharmacodynamics of the proposed biosimilar denosumab GP2411 and reference denosumab in healthy males. Expert Opin Biol Ther. 2024 Jan 25:1-10. doi: 10.1080/14712598.2024.2308645. Epub ahead of print. PMID: 38269652.