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
UsernamePublicRestriction

Not Just Herceptin Biosimilar: Additional 12 Drugs Set For EU Marketing Approval After CHMP Nod

Executive Summary

New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.

You may also be interested in...



EU CHMP OKs New Treatments For MS, Esophagitis, CMV, Hemophilia – & First Biosimilar Avastin

The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.

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

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 The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.

Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM003387

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