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

Amgen/Allergan Target Lucrative Avastin Market With Another Biosimilar Filing

Executive Summary

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.

You may also be interested in...



CHMP's November Recommendations Include Suliqua, Vemlidy And Afstyla

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for EU marketing authorizations.

Bevacizumab Biosimilar Nears Market As Amgen Files First At FDA

What is believed to be the first biosimilar version of Roche's Avastin to be filed with the US FDA has come from Amgen working in collaboration with Allergan, with the two companies heading a dozen-strong group of companies racing to develop versions of the monoclonal antibody.

Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway

Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.

Topics

Related Companies

UsernamePublicRestriction

Register

GB001654

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