US firm AbbVie and Iceland-based Alvotech have announced a resolution to the patent and trade secret disputes regarding Humira (adalimumab), for which Alvotech is developing a biosimilar.
On 8 March 2022, AbbVie and Alvotech announced a resolution to the US litigation regarding Alvotech’s biosimilar of Humira (adalimumab), a monoclonal antibody treatment for a range of inflammatory conditions.
Alvotech’s biosimilar, AVT02, is a high-concentration (100 mg/mL), citrate-free version of Humira. Over 80% of prescriptions in the US are for the high-concentration version of the product.
The litigation included a trade secrets lawsuit in which AbbVie accused Alvotech of recruiting a manufacturing executive, who supposedly sent himself sensitive information about Humira’s production before leaving the company. This led to AbbVie bringing forth an International Trade Commission (ITC) action in December 2021 to bar imports or sales of AVT02 in the US.
It also included a separate patent lawsuit, in which Alvotech challenged AbbVie’s patents on Humira. Alvotech previously raised a complaint against AbbVie alleging it was incorrectly sued over a Humira biosimilar application . With the resolution, both lawsuits are dismissed.
The resolution means Alvotech could launch AVT02 on the US market by the summer of 2023, as AbbVie will grant Alvotech a licence to its Humira-related patents in the US taking effect on 1 July 2023. Alvotech will pay royalties to AbbVie for licensing its patents.
Alvotech completed a switching study for AVT02 in June 2021, which aims to support its approval as an interchangeable biosimilar in the US . This would allow pharmacists to substitute AVT02 for Humira at the pharmacy counter. The US Food and Drug Administration (FDA) say they will deliver a decision on this by December 2022.
Róbert Wessman, Founder and Chairman of Alvotech, commented on the news: ‘We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment. We view today as a key milestone for patients and for our mission to fight for healthcare sustainability’.
AVT02 has also received approval in Canada , the EU and the UK. Amgen is also developing a Humira biosimilar (Amjevita), which it plans to launch on the US market in January 2023 .
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2. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Celltrion proceed with adalimumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/research/alvotech-and-celltrion-proceed-with-adalimumab-and-rituximab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab biosimilars Simlandi and Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/news/canada-approves-adalimumab-biosimilars-simlandi-and-yuflyma
4. GaBI Online - Generics and Biosimilars Initiative. Amgen predicts a steady flow of biosimilar launches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/biosimilars/general/amgen-predicts-a-steady-flow-of-biosimilar-launches
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