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

Biosimilar Advisory Committee Features Actual Debate About Biosimilarity

Executive Summary

FDA says problem with protein misfolding with Sandoz' Enbrel biosimilar candidate unlikely to generate unique toxicity issues in extrapolated indications.

You may also be interested in...



Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same

US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.

Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same

US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.

Biosimilar Litigation: Battles Continue Over Launch Notification, Access To FDA Info

A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS118765

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