Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

FDA Committee Recommends Amgen’s Enbrel For Approval In Pediatric Psoriasis

This article was originally published in The Pink Sheet Daily

Executive Summary

Panel sees benefit of giving physicians freedom to choose the treatment and gaining further data through Amgen’s proposed safety registry and ongoing study.

You may also be interested in...



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.

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.

FDA Panel Unanimously Recommends Centocor’s Ustekinumab

But Dermatologic and Ophthalmic Drugs panel says the proposal for long-term safety follow-up is inadequate.

Related Content

Topics

UsernamePublicRestriction

Register

PS067929

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