EU approval for Mvasi, first Avastin biosimilar

19 January 2018

The European Commission (EC) has granted marketing authorization for Mvasi (biosimilar bevacizumab), from US biotech major Amgen (Nasdaq: AMGN) and Ireland-incorporated Allergan (NYSE: AGN).

The approval comes after a positive recommendation from the European Medicines Agency’ appraisal unit in November and follows approval from the US Food and Drug Administration in September last year, making it the first biosimilar in the USA of Swiss pharma giant Roche’s (ROG: SIX) blockbuster cancer drug Avastin.

Avastin retains patent exclusivity until 2019 in the USA and until 2022 in Europe. Shortly after Amgen received FDA approval for Mvasi, Roche subsidiary a Genentech and Amgen filed competing lawsuits regarding patent infringement.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK