DrugName : adalimumab
AbbVie, a research-based global biopharmaceutical company, announced a global resolution of all intellectual property-related litigation with Sandoz over its proposed biosimilar adalimumab product.
Under the terms of an agreement signed by the companies, AbbVie will provide Sandoz with a non-exclusive licence to its intellectual property associated with Humira.
The licence will begin on certain dates in certain countries where AbbVie has intellectual property.
In the US, the period will commence on 30 September 2023. However, it begins early on 16 October 2018 in the majority of the European Union countries.
AbbVie external affairs executive vice-president Laura Schumacher said: “AbbVie’s Humira patents reflect the groundbreaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation.
“We continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation. This agreement accomplishes both objectives.”
Adalimumab is an anti-tumour necrosis factor (TNF) medicine indicated to treat various inflammatory disorders. Sandoz’s biosimilar Hyrimoz obtained European Commission (EC) approval in July.
In January last year, the US Food and Drug Administration (FDA) agreed to review the biologics licence application (BLA) for the proposed Humira biosimilar, Hyrimoz.
Sandoz Biopharmaceuticals global head Stefan Hendriks said: “In order to realise 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.”
Sandoz will pay royalties to AbbVie for licensing the Humira patents. Any pending litigations between the companies will be dismissed.
This follows agreement between AbbVie and Amgen in September 2017 over the latter’s biosimilar to Humira called Amgevita. AbbVie will grant patent licenses for the use and sale of Amgevita worldwide, on a country by country basis.