Canada Steers Away From Using Suffixes in Biologics' Names

Regulatory NewsRegulatory News | 18 February 2019 |  By 

Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the US the only country in the world to use such suffixes.

“Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix,” a notice to stakeholders said. “Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the same non-proprietary name can be distinguished by their unique brand names.”

The decision comes as Health Canada took into consideration the fact that all biologics, including biosimilars, have unique Drug Identification Numbers (DIN), which can help distinguish key characteristics of a product, including the brand name, manufacturer name, medicinal ingredient(s), strength(s), dosage form and route of administration.

And in explaining its decision to take this path, Health Canada said it sought to avoid the complexity that the US has seen and will continue to see moving forward as implementation progresses with the retroactive application of suffixes to previously authorized biologics. Health Canada also said its decision avoids any potential perception that different suffixes indicate clinically meaningful differences between a biosimilar and its reference biologic.

“An analysis of how biologic drugs, including biosimilars, are identified in Adverse Drug Reaction (ADR) reports in Health Canada’s Canada Vigilance database shows that reporting by brand name is largely successful in achieving accurate product-level attribution of spontaneously reported adverse events for suspected biologics,” Health Canada said.

Still, the Canadian regulator says that more work needs to be done to assist its pharmacovigilance efforts. For instance, Health Canada said it will update reporting forms and associated instructions in support of reporting brand and non-proprietary names, as well as product specific identifiers.

Canada will also prepare for mandatory reporting of serious adverse events and medical device incidents by health care institutions.

Notice to Stakeholders - Policy Statement on the Naming of Biologic Drugs


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