Revising the Guidance Document for Biosimilar Agents
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Abstract
Health Canada, the national department responsible for regulating food, health and consumer products to keep Canadians safe, published the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs on 14 November 2016 to update its framework for the market authorization of biosimilars in Canada. Biosimilars are the off-patent copies of biologics, a class of therapeutic agents derived from complex organic processing. Biosimilars are only “similar and not identical” to their reference biologic because biologics cannot be perfectly duplicated. As a result, biosimilars may not have the same safety profile as their reference biologic. As a number of biologics will be coming off patent in the coming years, Health Canada’s goal was to prepare by updating and clarifying the process surrounding market authorization.
Santé Canada, le ministère en charge de la réglementation des produits de consommation et des produits de santé au Canada, a publié le 14 novembre 2016 la Ligne directrice : exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaires, pour actualiser le cadre législatif des autorisations de mise sur le marché de biosimilaires au Canada. Les biosimilaires sont des copies de médicaments biologiques (une classe d’agents thérapeutiques issus de procédés organiques complexes) dont le brevet a expiré. Les biosimilaires sont “similaires mais non identiques” à leur médicament biologique de référence, parce que des médicaments biologiques ne peuvent être parfaitement dupliqués. Il en résulte que les biosimilaires ne peuvent offrir tout à fait les mêmes garanties d’emploi que leur médicament de référence. Compte tenu du fait qu’un grand nombre de brevets de médicaments biologiques vont expirer dans les années à venir, le but de Santé Canada était de se préparer en actualisant et clarifiant son processus de mise sur le marché.
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