AbbVie has entered patent licence agreements with Mylan for the proposed biosimilar product of its Humira (adalimumab) drug.
Adalimumab is an anti-inflammatory, TNF-inhibitor indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, chronic psoriasis, ulcerative colitis, hidradenitis suppurativa and juvenile idiopathic arthritis.
Under the agreements, AbbVie will grant a non-exclusive licence to Mylan for Humira’s intellectual property in the US, as well as other relevant international markets except Europe, on certain dates.
With the launch of Mylan’s biosimilar product following the initiation of its license on 31 July 2023, the company will be required to make royalty payments to AbbVie for the licensing of Humira patents.
AbbVie external affairs executive vice-president, and general counsel and corporate secretary Laura Schumacher said: “AbbVie’s Humira patents reflect the ground breaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation.
“We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance.”
AbbVie has previously signed similar agreements with Amgen and Samsung Bioepis.
In September last year, AbbVie and Amgen entered into settlement agreements for the global resolution of an intellectual property-related litigation over a proposed biosimilar of Humira.
The agreements provided Amgen with a non-exclusive license to intellectual property relating to Humira. The company’s licence period in the majority of the European Union countries begins on 16 October 2018 and 31 January 2023 in the US.
The terms of the agreement were the same for the litigation resolution with Samsung Bioepis in April this year. However, this licence period in the US commences on 30 June 2023.