DIA Biosimilars 2013

The nonclinical studies consist of pharmacology, pharmacokinetics and/or toxicology studies, and while the nonclinical studies are an important component of the biosimilarity exercise, the regulatory authorities generally recommend an abbreviated approach (vs. the traditional nonclinical package) be applied in demonstrating a proposed biosimilar is similar to the reference product. Certain challenges must be addressed when conducting comparative nonclinical studies, including selection of relevant in vitro and/or in vivo models and the development of the analytical assays. This presentation will review the various points that should be considered in designing a nonclinical package as part of the biosimilarity exercise, as well as provide an overview of the challenges that often arise when performing these nonclinical studies.