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Fresenius Kabi Succeeds In Canadian Adalimumab Tussle

Court Order Provides For Immediate Marketing Authorization

Executive Summary

Fresenius Kabi has been forced to wait to gain a Notice of Compliance, effectively a marketing authorization, for its Idacio (adalimumab) biosimilar to Humira in Canada, in light of the Minister of Health’s interpretation of regulatory language. However, a Federal Court has now found that earlier decisions by the Ministry barring approval were unreasonable.

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