Erelzi Clinical Development Timeline
Chronicle of the development and FDA review of Sandoz’s etanercept-szzs (GP2015), a biosimilar to Amgen’s Enbrel.
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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.
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.
FDA staff who participated in the review of Sandoz’s biosimilar etanercept-szzs.