Learn about Health Canada’s definition of extrapolation, their guidance for clinical trials and their rationale for selected biosimilar endpoints. Also covered is a case study for a biologic medication where extrapolation had occurred.
Learn about how Health Canada and other regulators use clinical and non-clinical data about biologics and biosimilars to approve indications for which clinical trials were not conducted. It provides Health Canada’s definition of extrapolation and shares the history of extrapolation in the European Union (EU).
To further expand on the concept of extrapolation, a case study is presented where extrapolation was carried out with a biologic medication. This case, documented by the European Medicines Agency (EMA), demonstrates how extrapolation is a common process when approving medications.
Also covered is Health Canada’s guidance for clinical trials and the rationale for the selected biosimilar endpoints.
This video is for healthcare providers, specifically oncologists and pharmacists.
Find more educational resources on biologics and biosimilars for healthcare providers:
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