Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018
By Pharmaceutical Technology Editors

On Oct. 11, 2018, Sandoz, a Novartis division, announced a global resolution of all intellectual property (IP)-related litigation with AbbVie concerning Sandoz’s proposed biosimilar, Hyrimoz (adalimumab), to AbbVie’s Humira (adalimumab). The resolution paves way for a 2018 launch of Sandoz’s product in key European markets and secures United States market entry, which is planned in 2023, Sandoz reports. Humira is AbbVie’s highest revenue-grossing product with $18.4 billion in 2017 sales.

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 Oct. 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 Sept. 30, 2023.

Sandoz will pay royalties to AbbVie for licensing its Humira patents. In addition, 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 biosimilar adalimumab was recently approved by the European Commission for the 31 countries of the European Economic area, which comprises the 28 member countries of the EU plus Norway, Iceland, and Liechtenstein. It is the seventh approved Sandoz biosimilar medicine.

"In order to realize the promise of early and expanded access and healthcare savings, biosimilars must be available as soon as possible to the patients and physicians who need them. This settlement helps remove uncertainty regarding when our biosimilar adalimumab will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease," said Stefan Hendriks, global head of Biopharmaceuticals, Sandoz, in a company press release.

Source: Novartis

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