Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by […]

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