Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin

Executive Summary

At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Advertisement

Related Content

BI’s Cyltezo Becomes 15th EU Biosimilar This Year, Adds To Pressure On Humira
Roche Finally Gets EU CHMP OK For Ocrevus Amid Access Concerns
EU CHMP To Review July Rejection Of Drugs For Schizophrenia, Metastatic Breast Cancer
Questions Surround Merck’s Withdrawal Of Keytruda Filing For Lung Cancer In EU
Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up
Not Just Herceptin Biosimilar: Additional 12 Drugs Set For EU Marketing Approval After CHMP Nod

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS121937

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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