AbbVie and Alvotech settle Humira (adalimumab) disputes

INICIO/Noticias Farmacéuticas | Posted 18/03/2022 post-comment0 Post your comment

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.

19646665_l

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 [1]. 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 [1]. 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 [3], 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 [4].

Related articles
EMA recommends approval of two adalimumab biosimilars

EMA and FDA accept application for adalimumab biosimilar AVT02

Biosimilars of adalimumab

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View this week’s headline article: Nomenclatura de biológicos y biocomparables en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

LATIN AMERICAN FORUM

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Nomenclatura de biológicos y biocomparables en México

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

References
1. GaBI Online - Generics and Biosimilars Initiative. AbbVie antitrust investigation and Sandoz biosimilar delay [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18]. Available from: www.gabionline.net/pharma-news/AbbVie-antitrust-investigation-and-Sandoz-biosimilar-delay
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: AbbVie; Alvotech

comment icon Comments (0)
Post your comment
Related content
Genfar: La nueva marca de genéricos de Eurofarma en América Latina
10 AA008993
INICIO/Noticias Farmacéuticas Posted 12/12/2023
Cuba y China estrechan lazos en biotecnología
134 AA010709
INICIO/Noticias Farmacéuticas Posted 01/09/2023
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010