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

Hospira, Korea’s Celltrion Get EU Nod For First Monoclonal Antibody Biosimilar

Executive Summary

EMA recommends approval for two brands of Celltrion’s infliximab, one to be marketed by Hospira, as Europe moves closer to its first MAb biosimilar. The positive decision is significant not only because the product will take on J&J/Merck’s bestselling Remicade in an era of budgetary pressures, but also because of its breadth. It is for all indications already approved in Europe for Remicade.

You may also be interested in...



Biosimilar Remicade Will Pit Rising Cost Pressures Against Prescriber Caution

If approved in Europe this year, as expected, Celltrion/Hospira’s biosimilar infliximab will provide a compelling test of whether and how quickly budgetary pressures can override physician caution. It will also set the stage for the $70 billion worth of copycat antibodies in development.

Korea's Celltrion In Deal With U.S.-based Hospira For Biogeneric Sales; M&A Hinted At

SEOUL - South Korea's Celltrion inked an agreement with U.S.-based Hospira to collaborate on manufacturing and marketing Celltrion's eight biogeneric products in global markets including the U.S. and Europe

Early-Stage Idiopathic Pulmonary Fibrosis (IPF) Candidates Race to Phase III

Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS055448

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