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Biosimilar Sponsors Took Delivery Device Shortcuts For Erelzi, Amjevita

Executive Summary

Sandoz’s and Amgen’s biosimilars employ autoinjectors that are currently used with the sponsors’ novel biologic products, allowing them to avoid additional human factors study testing of the delivery devices.

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Chronicle of the development and FDA review of Sandoz’s etanercept-szzs (GP2015), a biosimilar to Amgen’s Enbrel.

Sandoz Tested Erelzi’s Suffix On Multiple Fronts

Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.

Interchangeability: FDA Sets ‘Stringent’ Standard On Design Differences

Sponsors must assess any differences in a biosimilar’s container closure system or delivery device relative to the US reference product and may need to conduct comparative use human factor studies to ensure there is no increased risk of use-related error with the biosimilar.

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