Canada rejects biologic suffix addition leaving US only proponent
Health Canada made the decision as to how to identify proprietary biologic drugs from non-proprietary competitors, such as biosimilars, after consultation from stakeholders.
The department responsible for health in Canada settled on biologics drugs being delineated by unique brand name, non-proprietary name and their unique drug identification number (DIN).
Health Canada explained why differentiators are required: “Since a biosimilar and its reference biologic drug are not identical and are manufactured by independent processes, newly identified safety issues that affect the reference biologic drug may or may not also affect the biosimilar and vice-versa.”
At the same time, Canada’s federal institute rejected the possibility of adding a product-specific suffix, which leaves the US Food and Drug Administration (FDA) as the only regulatory body requiring such an identifier.
The FDA’s decision to adopt four-letter suffixes was initiated in January 2017 and was met by controversy in some sectors of the industry.
The agency stipulated that the suffix appended to the non-proprietary name should be ‘devoid of meaning’. For example, the biosimilar product Ontruzant, Samsung Bioepis’ biosimilar to Roche’s Herceptin, also carries the non-proprietary name trastuzumab-dttb.
Biosimilar producers argued that randomised suffixes would make them more difficult for physicians and patients to remember when highlighting issues, instead suggesting that the suffixes should have been allowed to be meaningful.