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Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

Executive Summary

Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.

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Biosimilars: Some Patient And Prescriber Groups Appear To Warm Up To Arbitrary Suffixes

Patient and prescriber groups were largely opposed to suffixes for the nonproprietary names of biological products being devoid of meaning when the US FDA first published its nomenclature policy, although a few of these groups may be signaling less of a worry than they once had. 

FDA Biosimilars Acting Director Yim Is ‘Not A Great Fan’ Of Suffix-Based Naming Policy

Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.

US FDA Biosimilars Acting Director Yim ‘Not A Great Fan’ Of Suffix-Based Naming Policy

Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.

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