Watch this video for more information on how biosimilars are made
Developing a biosimilar medicine requires significant expertise to ensure that it is “highly similar” to the reference biologic with no clinically meaningful differences in terms of safety and efficacy. This means extensively identifying and comparing the structural and functional properties of the biosimilar, using state-of-the-art technology. For a biosimilar, comparative structural and functional characterization will provide the greatest contribution to clinical predictability.