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.
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US Must Rethink Biologic Naming Suffix, Says IGBA
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.
Canada Gears Up For Expected Rise In Biosimilar Filings
Efforts are under way in Canada to strengthen the regulator’s ability to evaluate the growing number of biosimilar filings, and to increase confidence in the biosimilar regulatory framework through targeted outreach and education activities.
Australia Says No To ‘Complex’ US-Style Suffixes For Biologicals
Australia's Therapeutic Goods Administration wants to avoid the complexity and potential confusion associated with the introduction of a suffix-based system for naming biological medicines. The TGA has instead decided to supplement its existing naming convention for biologicals with a strengthened framework for reporting adverse events.