Pharmacokinetics (PK) Comparability for Follow-On Biologics

• Activity Number: 393
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jason Liao*+
• Companies: Merck Research Laboratories
• Keywords: Biosimilarity ; Follow-on biologics (FOB) ; Comparability ; Pharmacokinetics (PK) ; Ratio of geometric mean (MGR) ; Reference-scaled

Abstract

With the rising spending and approaching patent expiration of biologics, biosimilar is a topic of much debate, not only among pharm and biotech companies, but also major regulatory bodies such as US FDA and the European Medicines Agency. The traditional classic chemical synthesized generic drug was introduced with only limited data needed for market approval, which, however, cannot be extrapolated to biologics. In the biologics scenarios, the comparability of efficacy and safety from the clinical trials, and the comparability of pharmacokinetics and pharmacodynamics parameters are the key for the success of follow-on biologics. In this talk, we focus on the comparability of pharmacokinetics. We propose a reference scaled method to demonstrate the comparability of pharmacokinetics parameters and a real data set is used to demonstrate the proposed approach.