Biosimilar Development: Analytical Perspective

Gabriela Ridner-Bahar, Global R&D, Teva Pharmaceuticals, Netanya , Israel (gabriela.ridner-bahar@teva.co.il)

Biosimilar development is a complex process in which the biosimilar candidate should be highly similar to the reference product and should not show clinically meaningful differences in terms of safety, purity and potency. Different approaches will be presented demonstrating Bios. Development challenges, and the analytical perspective in terms of product characterization.