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Registering Biosimilar Drugs with Health Canada
Welcome to DDReg Knowledge Capsule! In this episode, we explore Health Canada's regulatory framework for registering biosimilar biologic drugs. We break down the fundamental differences between biosimilars and generic small-molecule drugs, explain why biosimilars are authorized through the New Drug Submission (NDS) pathway, and discuss the pivotal role of the Canadian Reference Biologic Drug (CRBD). Listeners will also gain actionable insights into scientific reviews by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), indication extrapolation requirements, and post-market…
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