Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



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.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS120207

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel