This will be an interesting session for the industry, especially with the looming patent cliff for biologics. The data package for biosimilars must establish similarity with the reference product based on the totality of the comparability evidence. The evidence includes bioanalytical, preclinical, clinical, safety and immunogenicity studies.
This session will provide some ‘real life’ case studies from the Industry perspective including an overview of the relevant guidelines. The TGA will provide their perspective on the issues they consider in the evaluation of biosimilars and extrapolation of indications.
Chairperson: Katy King, Biotech Regulatory Solutions