Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?

ConclusionOur analysis reveals that, in most cases, the reference biological products originated from the EU and those from the USA are almost indistinguishable in terms of PK/PD properties. Additional in vivo bridging studies between reference products from different global regions may not be required if similar physicochemical and structural properties are evident in vitro.
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research