AbbVie and Sandoz, Novartis’ generics arm, have signed a resolution of all intellectual property (IP)-related litigation concerning Sandoz’s Hyrimoz (adalimumab), a proposed biosimilar to AbbVie’s anti-inflammatory drug, Humira (adalimumab), AbbVie’s top-selling drug with 2017 sales of $18.43 billion.

Under the agreement, AbbVie grants Sandoz a non-exclusive license to AbbVie’s IP relating to Humira, beginning on certain dates in certain countries in which AbbVie has IP. The license period will begin on October 16, 2018 in most countries in the European Union (EU), and on other dates in various other countries outside the US where AbbVie has IP. In the US, the license period will begin on September 30, 2023.

Sandoz will pay royalties to AbbVie for licensing its Humira patents. All litigation pending between the parties will be dismissed. AbbVie will make no payments to Sandoz. The precise terms are confidential between the parties.

Sandoz’s adalimumab biosimilar was recently approved by the European Commission (EC) for the 31 countries of the European Economic area, which comprises the 28 member countries of the European Union plus Norway, Iceland and Liechtenstein. It is the seventh approved biosimilar from Sandoz.

Novartis is the fourth company to form a licensing deal with AbbVie for biosimilars of Humira. AbbVie previously formed similar agreements with Mylan, Amgen, and Samsung Bioepis, a biosimilars joint venture of Biogen and Samsung BioLogics, an Incheon, South Korea-based contract biologics manufacturer. Under the deals, Amgen will launch its Humira biosimilar in the US in January 2023, and subsequently Samsung Bioepis in June 2023, Mylan in July 2023, and Sandoz in September 2023. In the EU, all four companies plan to launch the biosimilars October 16, 2018. 

Source: Novartis