Alvotech and AbbVie settle Humira biosimilar patent dispute

9 March 2022

Privately-held Icelandic biosimilars developer Alvotech Holdings says it has executed a US settlement agreement with AbbVie (NYSE: ABBV) that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the USA. The settlement grants Alvotech a license entry date in the USA of July 1, 2023.

The settlement fully resolves all pending US disputes between AbbVie and Alvotech related to AVT02, including the US International Trade Commission (ITC) case brought forth in December 2021, thus removing any corresponding litigation-related barriers blocking Alvotech’s high-concentration version of adalimumab from reaching US patients.

“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert Wessman, founder and chairman of Alvotech, adding: “We view today as a key milestone for patients and for our mission to fight for healthcare sustainability.”

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