New adalimumab biosimilars prepare to launch in Canada, US and Europe

Biosimilars/News | Posted 16/05/2022 post-comment0 Post your comment

Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.

Adalimumab V13F21

Several adalimumab (Humira) biosimilar products are preparing to launch on new markets. Adalimumab is a monoclonal antibody treatment for a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and inflammatory bowel disease (IBD). Injected under the skin, it works by targeting the inflammatory molecule tumour necrosis factor alpha (TNF-α). It is sold by the originator company AbbVie under the brand name Humira.

In April 2022, BIOJAMP, the biosimilars division of Canadian pharmaceutical company JAMP Pharma Group, announced a partnership with Accessa – a subsidiary of AQPP (Association québécoise des pharmaciens propriétaires du Québec) in Canada to increase access to their adalimumab biosimilar, Simlandi.

Simlandi is a high-concentration, low-volume, citrate-free adalimumab biosimilar, which means only half the volume needs to be injected compared to originator Humira. The biosimilar will be available in two doses – 40 mg and 80 mg – the latter of which, BIOJAMP says, will allow some patients to reduce their injections by half. This high-dose formulation is also the formulation used by more than 80% of patients in the US.

President and Chief Operations Officer of JAMP Pharma, Bruno Mäder, said: ‘BIOJAMP's mission is to facilitate and improve the experience of patients and healthcare professionals with biosimilars. It is therefore a natural fit for us to tap into the expertise of the vast network of community pharmacies through Accessa to support and simplify access to SimlandiMC’.

Jean Bourcier, President of Accessa, added: ‘Accessa is the logical next step in the evolving role of pharmacists. They have the expertise to manage complex treatments for their patients in a comprehensive manner and to optimize their effectiveness. Effective treatment means a better quality of life for patients and increased support for the first line of care’.

In the US meanwhile, Celltrion, a South Korean company, has also announced plans to begin selling its adalimumab biosimilar, Yuflyma [1]. The company plans to start selling the biosimilar on the US market from July 2023, following originator company AbbVie’s patent expiry in January 2023.

This follows the news of a patent agreement with AbbVie, which will allow Celltrion to market a high-concentration formulation of adalimumab. Yuflyma has been approved in the EU, Korea and Canada [2] but is currently awaiting approval from the US Food and Drug Administration (FDA).

A spokesperson for Celltrion said: ‘By entering the US market early, we expect to show the differentiated competitiveness of the high-concentration Humira biosimilar to patients with autoimmune diseases in the US’.

Similarly, Iceland-based company Alvotech has also resolved its European patent disputes with AbbVie, relating to Alvotech’s adalimumab biosimilar AVT02. This follows the news that Alvotech had settled pending disputes with AbbVie in the US [3].
 
The announcement means that all disputes related to AVT02’s market entry in the US and Europe are now resolved. This means Alvotech has a non-exclusive, royalty bearing licence to AbbVie’s intellectual property relating to Humira in Europe and other markets.
 
Alvotech’s strategic partner, STADA, will commercialize AVT02, which is also a citrate-free, high-concentration formulation of adalimumab. It will be sold under the brand name Hukyndra.

Robert Wessman, Founder and Chairman of Alvotech, commented: ‘This resolution is an important step in Alvotech’s mission to bring more sustainable health care to patients in need and we look forward to launching our first biosimilar in the European market with STADA’.

Peter Goldschmidt, CEO of STADA, added: ‘Hukyndra will be the first of what we anticipate will be a continuous stream of biosimilar launches across a broad range of therapeutic categories through our partnership with Alvotech. We are committed to working with partners to bring competition to the biologic medicines sector, thereby delivering value and facilitating patient access’.

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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: Nuevos biosimilares de adalimumab se preparan para su lanzamiento en Canadá, EE.UU. y Europa

Browse the news in the Latin American Forum!

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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: Nuevos biosimilares de adalimumab se preparan para su lanzamiento en Canadá, EE.UU. y Europa

!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. Celltrion updates on Remsima and Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 16]. Available from: www.gabionline.net/biosimilars/news/celltrion-updates-on-remsima-and-yuflyma
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab biosimilars Simlandi and Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 16]. Available from: www.gabionline.net/biosimilars/news/canada-approves-adalimumab-biosimilars-simlandi-and-yuflyma
3. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Alvotech settle Humira (adalimumab) disputes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 May 16]. Available from: www.gabionline.net/pharma-news/abbvie-and-alvotech-settle-humira-adalimumab-disputes

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Source: BIOJAMP, JAMP Pharma Group; Celltrion; Alvotech

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