Description

This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical package as part of the submission.

Resources

Name	Format	Description	Link
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs-1.html#obj
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/exigences-matiere-renseignements-medicaments-biologiques-biosimilaires-1.html#sco

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