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US Must Rethink Biologic Naming Suffix, Says IGBA

Executive Summary

In the wake of a decision by Health Canada not to implement a suffix to non-proprietary names to distinguish biosimilars from their branded counterparts, the IGBA has urged the FDA to reconsider the US approach.

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Canadian Decision On Biological Names Leaves US As The Outlier

Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as the only major territory to operate such a convention. The move has been welcomed by the Canadian generics industry.

Canada Decides Against Suffix-Based Biologics Naming System

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.

Broad alliance queries FDA’s suffixes stance

The US Food and Drug Administration (FDA) should clarify its current thinking on whether biosimilars and original biologics should addafour-letter meaningless suffix to the non-proprietary names of their products, according to a broad coalition covering biosimilar developers, health insurers, pharmacy benefit managers (PBMs), retailers, doctors, pharmacists and consumers. “Does this still represent the agency’s current thinking?” the alliance queries in a submission to a docket on facilitating competition and innovation in the biological products marketplace.

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