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Drug Review Profile Biosimilars Regulation

Erelzi Clinical Development Timeline

  • Analysis

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.

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Drug Review Profile Biosimilars Regulation
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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