Erelzi Clinical Development Timeline
Executive Summary
Chronicle of the development and FDA review of Sandoz’s etanercept-szzs (GP2015), a biosimilar to Amgen’s Enbrel.
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Biosimilar Sponsors Took Delivery Device Shortcuts For Erelzi, Amjevita
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.
Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel
Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.
Erelzi Reviewers
FDA staff who participated in the review of Sandoz’s biosimilar etanercept-szzs.