Posted by Michael Wonder on 20 Feb 2019
Diverging from FDA, Health Canada announces suffix-free biologic and biosimilar naming convention
18 February 2019 - Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix.
Health Canada has announced 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.
Every biologic will also continue to have a unique Drug Identification Number (DIN) that distinguishes key product information, such as brand name, manufacturer name, strength, ingredients, dosage form, and route of administration. However, DINs will no longer be used as the standard approach to identifying products in Canada.
