Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan

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Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan.


The news follows the US$50 million investment by Fuji Pharma in Alvotech back in November 2018. This gave Fuji Phama a 4.2% stake in the biopharmaceutical company, which is focused on the development of biosimilars [1].

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

The originator product, Johnson & Johnson’s Stelara (ustekinumab) had worldwide net sales of US$5.2 billion in 2018, making it a lucrative target for biosimilars developers. The patents on Stelara will expire in the US in September 2023 and in Europe in January 2024 [2]. In most other countries, the latest projected expiration date is 2021.

The deal gives Fuji Pharma exclusive rights to commercialize biosimilar Stelara in Japan. Under the terms of the agreement, Alvotech will assume responsibility for full development and commercial supply, out of its new state-of-the-art manufacturing facility in Reykjavik, Iceland. Alvotech will receive an upfront payment of US$4.6 million as a part of the transaction, with rights to receive total milestone payments up to US$20 million.

Alvotech‘s has a pipeline containing six biosimilar monoclonal antibodies and fusion proteins aimed at treating severe immune, inflammatory conditions. The company also intends to add new products each year and ‘over time create a substantial portfolio of high quality, high value products’.

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1. GaBI Online - Generics and Biosimilars Initiative. Fuji Pharma acquires stake in Alvotech []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: 
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007

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Source: Alvotech, Johnson & Johnson

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