19/12/2024
A. Petrov, I. Makarenko, B. Belova, A. Melikyan, V. Saparova, K. Peskov, N. Kudryashova, V. Kovalik, M. Gefen, A. Khokhlov, R. Drai. (2024) Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia. Clin Pharmacol Drug Dev. Accepted on Dec 19, 2024. https://doi.org/10.1002/cpdd.1494
During the development of biosimilars, conducting a clinical trial of biosimilar efficacy in patients may be necessary when there is residual uncertainty regarding the biosimilarity of the products. A population pharmacokinetic/pharmacodynamic model for healthy volunteers was modified and validated to describe platelet dynamics in patients with immune thrombocytopenia. ISCTs were then conducted using the modified model for various expected biosimilar efficacy trial scenarios. Statistical analysis of the modeling results was subsequently used to confirm the appropriateness of the chosen design for assessing the planned efficacy endpoints.
Analysis of the ISCT results effectively reduced the uncertainty in the development of the GP40141 biosimilar, demonstrating the appropriateness of using the week 10 efficacy endpoint as the primary endpoint.
