Pfizer secures Humira licence agreements with AbbVie

Pfizer has resolved licensing issues regarding its adalimumab biosimilar that was deemed too close to AbbVie’s Humira (adalimumab).

Under the agreements, Pfizer gains a non-exclusive patent licence from AbbVie to use and sell its proposed biosimilar product in various markets globally.

In the US, the licence period will begin on 20 November 2023. Pfizer can introduce the adalimumab biosimilar in Europe after approval from the European Medicines Agency (EMA).

Pfizer Inflammation and Immunology global president Richard Blackburn said: "This settlement will facilitate patient access to Pfizer’s proposed adalimumab biosimilar, which we expect to be an important addition to our broad portfolio of biosimilar medicines."

Under the deal, Pfizer will pay royalties to AbbVie. The exact financial details of the agreement have not been disclosed by both parties.

"This settlement will facilitate patient access to Pfizer’s proposed adalimumab biosimilar."

Adalimumab is an anti-inflammatory, TNF-inhibitor indicated for the treatment of different inflammatory disorders. AbbVie’s European patent on Humira expired in October, leading the way for rival companies to move into the $20bn global market.

Major firms expected to launch Humira biosimilars include Fujifilm Kyowa Kirin Biologics, Amgen, Novartis subsidiary Sandoz, Biogen and Samsung Bioepis.

AbbVie signed an agreement with Sandoz in October, providing a non-exclusive licence to its intellectual property associated with Humira. During the period, five biosimilar variants of the drug received approvalfor launch in the European Union (EU).

AbbVie and Amgen entered an agreement in September, while deals with Mylan and Samsung Bioepis were signed in July and April respectively.

All deals involved resolution of any pending litigation with AbbVie.

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