Race for a slice of Humira revenues, as Amgen files first biosimilar MAA with EMA

6 December 2015

In a global biosimilars market expected to reach a value of $20 billion by the end of 2015 and could hit $55 billion by 2020, according to business intelligence provider GBI Research, the race for applications for approval of such “follow-on biologicals” is heating up.

The latest news is from US biotech major Amgen (Nasdaq: AMGN), which on Friday revealed it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 501, a biosimilar candidate to AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) which loses patent protection next year.

Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the European Union, where the regulatory approval path is already well established compared with that in the USA.

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