Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

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 have been identified by their brand names in almost every adverse event report received by the US FDA so far, lending credence to arguments against the necessity of a nonproprietary name suffix, even though the controversial policy still may prove useful for pharmacovigilance.

Of the more than 2,500 adverse event reports received for biosimilars through June 30, only 11 identified the product with...

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