Aparna Kasinath
Syngene International Limited
Title: Recommendations from the AAPS LBABFG Biosimilars Action Program Committee for the Validation Of Pharmacokinetic and Immunogenicity Assays in Support of Biosimilar Drug Development
Biography
Biography: Aparna Kasinath
Abstract
While, the development of Biologics is complicated and a strategy driven approach, mainly owing to the complexity and nature of the molecule, development and commercialisation of a Biosimilar is two fold challenging. The Biosimilar is not only required to meet safety and efficacy end points as with all biologics, but also must demonstrate comparability with its Innovator. Demonstration of comparability requires robust developed and validated assays that are able to pick out bioanalytical differences between the Biosimilar and Innovator. Pharmacokinetic and Immunogenicity assays are the major measurement platforms for safety and efficacy data arising from non clinical and clinical studies. Currently there are no regulatory guidelines that clearly define the process/ path to be taken for designing comparability assays. This talk is aimed at discussing the recommendations made by the AAPS Ligand Binding Assay team for a harmonized strategy for Biosimilar assay development and a One or Two assay bioanalytical strategy. This discussion is tailored to all biosmilar manufacturers and biosimilar bioanalytical scientists in particular.