The Use of Pharmacometrics to Optimize Biosimilar Development. Issue 11 (11th September 2013)

• Record Type: Journal Article
• Authors: Dodds, Mike; Chow, Vincent; Markus, Richard; Pérez‐ruixo, Juan José; Shen, Danny; Gibbs, Megan
• Is Part Of: Journal of pharmaceutical sciences. Volume 102:Issue 11(2013:Nov.)
• Page Start: 3908
• Page End: 3914
• Publication Date: 2013-09-11
• Subjects: Pharmacy -- Periodicals; 615.1
• DOI: 10.1002/jps.23697
• Languages: English
• ISSNs: 0022-3549

Abstract

<abstract abstract-type="main" xml:lang="en"> <title> <x xml:space="preserve">Abstract</x> </title> <p>Pharmacometric approaches can assist in biosimilar development by leveraging quantitative knowledge of the originator product characteristics such as dose–exposure and exposure–response information to support a targeted approach to clinical studies. The degree to which these approaches can be applied relies on the level of information known about the originator and information that supports application of the originator model to the biosimilar. A model‐based approach testing the hypothesis that the biosimilar PK and/or PK/PD profile is similar to the originator in the target patient population is aligned with the central comparability exercise required for the biosimilar approval. This Commentary details the key opportunities in study design and study analysis where pharmacometrics approaches can aid biosimilar development. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:3908–3914, 2013</p> </abstract>