Health Canada updates its biosimilar fact sheet

Center for Biosimilars

4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

The fact sheet incorporates a decision the Canadian regulator made earlier this year, when it updated its naming convention for biosimilars, deciding that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix. 

The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands. Health Canada says that biosimilars are distinguished by their unique brand names and other product-specific identifiers such as the Drug Identification Number.

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Michael Wonder

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Michael Wonder

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Canada , Biosimilar , Guidelines