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

Stelara Clears FDA; Different Class, But REMS Looks Similar To TNF Blockers

Executive Summary

Centocor Ortho Biotech's Stelara (ustekinumab) brings a novel mechanism and superior efficacy to the plaque psoriasis marketplace, but in terms of risk management, the anti-inflammatory biologic differs little from the tumor necrosis factor inhibitor class

You may also be interested in...



Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

Remicade: A Study In Translational Looping

The lifecycle of J&J’s TNF inhibitor Remicade – a “pipeline in a product” – highlights how the company used the knowledge gained from one product to improve and expand its portfolio.

Roche's Actemra Approved For RA After Year's Delay - To Craft A REMS?

Roche's novel interleukin-6 inhibitor Actemra won FDA approval Jan. 8 for second-line use in rheumatoid arthritis - after an FDA "complete response" letter set the product's regulatory process back more than a year

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051528

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