The development of rituximab biosimilars is urgently needed to give patients access to high-quality and affordable treatments. This recently published study compares the pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PKPD) profiles of a rituximab biosimilar currently under development by Dr Reddy’s Laboratories SA (Basel, Switzerland) to the EU reference medicinal product for rituximab in patients with diffuse large B-cell lymphoma.
Here, we illustrate how population PK-PKPD analyses can be applied to identify hidden factors generating apparent differences between drug products and how they can contribute in multiple ways to PK similarity assessments. Such pharmacometric analyses represent an opportunity to support the development of new biosimilars, possibly shortening the time needed to make them available on the market.
Title of the publication: Rituximab PK and PKPD evaluation based on a study in diffuse large B-cell lymphoma: influence of tumor size on PK and assessment of PK similarity
Find the publication published in CPT Pharmacometrics Systems Pharmacology:
https://doi.org/10.1002/psp4.12885
Pharmetheus affiliates: Robin J. Svensson, Qing Xi Ooi, Lena E. Friberg, Emma Hansson and Viviana Moroso.
Dr. Reddy’s affiliates: Narendra Maharaj, Pramod Kumar Reddy, and Luis López-Lázar.