Biosimilars and Biologics

This presentation on biosimilar development will address the best bioanalytical approaches for evaluating differences between an original compound and biosimilar. An increasing number of patents for originator biologic products are due to expire, creating more industry opportunity in the area of biosimilars, and it is therefore important that we all align on best practices for their development. The immunogenicity assessment of biosimilar and originator drug products is one of the key aspects of clinical programs for biosimilars to demonstrate biosimilarity, and to establish that there are no clinically meaningful differences in immune response between a proposed product and the originator product. We will discuss considerations and formats for use in the development and validation of neutralizing antibody (NAb) assays to support biosimilar assessment.