Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development

"To ensure safety and efficacy of a biosimilar in comparison with its originator drug, preclinical and clinical comparabiltiy studies must be conducted according to the regulatory guidance for both the European Medicines Agency and the US FDA." Biopharmaceutical products (biologics) are active drug substances produced by living cells or derived from a living organism (bacteria, yeast, animal or human cell lines). Biosimilars, or follow-on biologics, are the subsequent versions of originator biopharmaceutical products following expiry of its patent and exclusivity. Biosimilars are also referred to as subsequent entry biologics in Canada.  Click here for the full article.