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Adverse event reports submitted to the US FDA for biosimilars almost always include the brand name, rather than the nonpriorietary name only, despite FDA guidance on the matter. Examine the data behind biosimilar adverse event reporting, and understand the implications of the FDA’s guidelines for naming biosimilars in such reports with the essential information in this Pink Sheet article. Included is the outcome of an internal Sandoz study of its Zarxio safety database and a look at ongoing education efforts aimed at ensuring the proper suffixes are being used in adverse event reporting for biosimilars.
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