AbbVie and Novartis’ Sandoz unit reached a global resolution of all intellectual property-related litigation over Sandoz’s proposed biosimilar Hyrimoz for the reference drug Humira (adalimumab).
Under the terms of the settlement, AbbVie has granted Sandoz a non-exclusive license to intellectual property relating to Humira beginning on beginning on October 16, 2018, in most countries in the European Union, and September 30, 2023, in the U.S. Sandoz will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity of the licensed patents. AbbVie will make no payments to Sandoz. The specific terms of payments were kept confidential.
Laura Schumacher, executive vice president, external affairs, general counsel, and corporate secretary, AbbVie stated, “We continue to believe biosimilars will play an important role in our health care system, but we also believe it is important to protect our investment in innovation. This agreement accomplishes both objectives.”
Global Head of biopharmaceuticals at Sandoz Stefan Hendriks commented, “This settlement helps remove uncertainty regarding when our biosimilar will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease.”
Novartis said this resolution is expected to allow for Hyrimoz’s 2018 launch in key European markets and also secures U.S. market entry planned for 2023.
European approval was granted for Hyrimoz in July, while its U.S. filing for the biosimilar remains under review by the FDA.