Generics Bulletin 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

First Biosimilar MabThera One Step Away from EU Approval; Pegfilgrastim Filings Withdrawn

Executive Summary

The CHMP has granted a positive opinion to Celltrion’s Truxima, the first biosimilar version of Roche’s cancer treatment, MabThera, but has announced the withdrawal of two pegfilgrastim products.

You may also be interested in...



Amgen/Allergan Target Lucrative Avastin Market With Another Biosimilar Filing

Amgen and Allergan have filed an EU marketing authorization application for their biosimilar version of Roche’s monoclonal antibody product for cancer, Avastin (bevacizumab). In doing so, they join a growing number of biosimilars awaiting approval by the European authorities.

COVID-19: EU Under Pressure To Open Up On Vaccine Costs & Contracts

Transparency on COVID-19 vaccine funding, pricing and procurement is vital if vaccine hesitancy and disinformation are to be countered, say EU parliamentarians.

Coronavirus Notebook: EU & Australia Assessing Comirnaty In 5-11 Year Olds, Aviptadil shows Promise In Critical COVID-19 Patients

The European Medicines Agency has OKd new manufacturing sites and a ready-to-use formulation for Comirnaty, while Australia has provisionally approved Ronapreve for treatment and post-exposure prophylaxis. The UK has secured supplies of two investigational antiviral products from Pfizer and MSD.

Topics

UsernamePublicRestriction

Register

GB002368

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