Clinical Information Requirements for Biosimilar Biologic Drug Approvals in Canada

Biologic medicines have been invaluable in the treatment of conditions ranging from cancer to autoimmune disease. The expiry of patents for many successful biologic medicines has fostered a high degree of interest in the development of subsequent entry versions, known as biosimilar biologic drugs or, simply, biosimilars. Biologics are structurally complex and more difficult to replicate than small molecule pharmaceuticals. Health Canada's guidance on biosimilar biologic drugs specifies rigorous comparisons of chemistry and manufacturing attributes, non-clinical aspects, as well as clinical studies comparing the pharmacokinetics/pharmacodynamics, safety and efficacy, and immunogenicity of a biosimilar biologic drug to its reference. When taken as a whole, evidence of similarity in each of these aspects allows for a conclusion of biosimilarity, meaning that, in any given setting, the biosimilar is expected to produce clinical outcomes that are not meaningfully different from those expected with the reference biologic drug. This chapter is intended to present the Canadian clinical information requirements for biosimilars, and how they relate to the Canadian regulatory framework, while putting these requirements into context with other aspects of a complete data package in support of biosimilarity.