Analysis·Biosimilars
Health Canada's biosimilar NOC starts a clock the originator can't stop
Notice of Compliance is the starting gun, not the finish line. Here's how the next 18 months of switching policy likely plays out.
The event
Health Canada issued a Notice of Compliance for a biosimilar to a reference monoclonal antibody, making it eligible for provincial formulary review.
A biosimilar NOC is market authorization, not market access — but it starts a clock that the originator can slow and never quite stop. The approval itself is the least interesting thing about the week.
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