Canada Decides Against Suffix-Based Biologics Naming System
Executive Summary
Following a consultation with stakeholders, the Canadian regulator says identification of biologics using their brand and non-proprietary names has emerged as the most preferred option as it is consistent with current practice.
More than a year after consulting with stakeholders on various options for a naming policy for biologic drugs, Health Canada has decided that such products should be identified by their unique brand name and non-proprietary name, without the addition of a product-specific suffix.
This means that both the brand name and non-proprietary name will be used for identifying biologics, including biosimilars, throughout the medication use process so that products sharing the same non-proprietary name can be distinguished from each other.
US Goes It Alone On Suffixes
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Canada's decision not to introduce a product-specific suffix leaves the US as the only country that requires a "meaningless" four-letter suffix to be attached to the international non-proprietary name of biologics to support their identification.
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Although Australia was considering adopting a suffix-based system, it decided against this option last year to avoid the complexity and potential confusion associated with such an approach. (Also see "Australia Says No To ‘Complex’ US-Style Suffixes For Biologicals" - Pink Sheet, 23 Jan, 2018.)
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In the EU, the identification of biologic drugs relies on brand name, non-proprietary name, lot number, and barcode.
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Japan has implemented a naming scheme specific to biosimilars, which includes the international non-proprietary name, plus “biosimilar” and a sequential number (eg filgrastim biosimilar 1) rather than a suffix.
The government department explained that it decided to go for this option after 75% of the 362 respondents who participated in a consultation exercise last year rated it as their preferred or acceptable option as it was compatible with their current practice or environment. (Also see "Canada Wants Views On Three Options For Naming Of Biologic Drugs" - Pink Sheet, 22 Jan, 2018.)
The other two options – to maintain the status quo or to adopt a US-style suffix system – did not receive as much stakeholder support. While 70% of respondents said the status quo option was not acceptable, the proposal for a suffix-based system drew support of 51% of respondents, who mostly represented consumers/patients, private insurers, educational and advocacy groups as well as some pharmaceutical companies. [About half of the respondents who preferred the suffix-based system also rated the option of identifying biologics with their unique brand name and non-propriety name as acceptable.]
Health Canada finally decided to go for the "most favoured option" as it does not impose unnecessary regulatory burden and "avoids the complexity associated with implementation of a suffix-based naming convention with retroactive application to previously authorized biologics." Also, this option avoids any potential perception that different suffixes indicate clinically meaningful differences between a biosimilar and its reference biologic drug, Health Canada added.
It said that under its new naming policy, all biologic drugs will continue to have a unique Drug Identification Number (DIN), which is a computer-generated 8-digit number assigned by Health Canada to uniquely distinguish the key characteristics of a drug product, including its brand name, manufacturer name, medicinal ingredient(s), strength(s), dosage form, and route of administration.
To help implement the policy, Health Canada said it would:
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- Update related guidance documents and issue a regulatory amendment to ensure that the current practice of sponsors submitting unique brand names for biologics is adequately supported.
- Issue communications on the importance of recording both brand and non-proprietary names throughout the medication use process (as well as other product-specific identifiers, such as DIN and lot numbers, where appropriate).
- Undertake activities to assist pharmacovigilance, such as updating adverse drug reaction (ADR) reporting forms and associated instructions to support reporting of brand and non-proprietary names as well as other product-specific identifiers.
Also, it intends to leverage current outreach activities being conducted in preparation for mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.
Current Practice
During the consultation process, several stakeholders, including prescribers, pharmacists, patients and drug information systems providers, told Health Canada that unique brand names are a key component for readily distinguishing among biologic drugs.
Moreover, an analysis of how biologic drugs, including biosimilars, are identified in ADR reports in the Canadian vigilance database showed that reporting by brand name is largely successful in achieving accurate product-level attribution of spontaneously reported adverse events for suspected biologics, although the traceability of biologics primarily used in hospital settings was identified as an area for improvement, the government department said.
Health Canada decided on finalizing a naming policy for biologic drugs last year following the entry of biosimilars into the Canadian market. In May, it announced plans to build up its capacity in anticipation of an increase in the number of biosimilar evaluations. (Also see "Canada Gears Up For Expected Rise In Biosimilar Filings" - Pink Sheet, 10 May, 2018.)
From the editors of Scrip Regulatory Affairs.