June 26, 2019: Health Canada's Policy Statement on the Naming of Biologic Drugs
Health Canada recently released a policy statement on the naming of biologic drugs, including biosimilars. A biosimilar is a biologic drug that has been demonstrated to be highly similar, with no clinically meaningful differences in safety and efficacy, to a biologic drug that has already been authorized for sale (known as the
reference biologic drug). Biosimilars and their reference biologic drugs share the same non-proprietary (common) name of the active ingredient. However, unlike the situation for chemically produced generic medications, a biosimilar and its reference product are not identical, and authorization of a biosimilar by Health Canada is not a declaration of equivalence with its reference biologic drug. In Canada, the concept of interchangeability refers to the ability for a pharmacist to change a patient's prescription from one medication to another equivalent medication, without the intervention of the doctor who wrote the prescription. Provinces and territories, which have authority over interchangeability, have not declared biosimilars and their respective reference biologic drugs to be interchangeable.
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