Biosimilar biologic drugs in Canada: Fact Sheet

Biosimilar biologic drugs in Canada: Fact Sheet A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs. 2022-06-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetybiosimilarbiosimilar biologic drugsauthorized for salebiosimilars for salebiologic drugs Biosimilar biologic drugs in Canada: Fact SheetHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html Biosimilar biologic drugs in Canada: Fact SheetHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/fiche-renseignements-biosimilaires.html

A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs.

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