New BioFactura-CuraTeQ partnership for ustekinumab biosimilar

CuraTeQ Biologics Private Limited, a subsidiary of India’s Aurobindo Pharma Limited, has entered into an exclusive license agreement to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).

According to BioFactura, ‘The CuraTeQ-BioFactura licensing deal will allow the parties to focus on improving outcomes, quality of life, accessibility, and enhancing the patient experience with high quality biosimilar medicines’.

Under the terms of the agreement, CuraTeQ has been granted exclusive license rights to commercialize BFI-751 in all major regulated markets including ANZ (Australia, New Zealand), Canada, European Union, UK, US and certain other semi-regulated and emerging markets worldwide. The product will be produced at CuraTeQ facilities in Hyderabad, India. BioFactura will receive license fees not exceeding US$33.5 million spread across various milestones in the lead up to commercialization and will obtain up to 43% profit sharing, dependent on region.

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 [1].

The global drug sales of ustekinumab neared US$10 billion in 2022 and the originator product is manufactured by Johnson & Johnson.

BioFactura now plans to begin a global phase III trial of the product. This follows the successful completion of phase I trials carried out in ANZ [2]. CuraTeQ hopes to file this product in India and emerging markets in 2024 and the regulated markets filing is scheduled to start in 2026.

In 2021, BioFactura entered an agreement with Rani Therapeutics to evaluate BFI-751 in its RaniPill capsule, a new, proprietary and patented platform technology, designed to be a pain-free way to replace the molecules being delivered by injection [3].

Patents expire for Stelara in the US in September 2023 and in Europe in January 2024 [4], and there are a number of other ustekinumab biosimilars in the pipeline. These are being developed by companies such as Alvotech [5], Celltrion [6], Fomycon [7] and Dong A ST [8].

Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
www.gabionline.net/biosimilars/research/clinical-trials-begin-for-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars: new international biopharma agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/pharma-news/ustekinumab-biosimilars-new-international-biopharma-agreements
4. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ustekinumab biosimilar AVT04 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from:
www.gabionline.net/biosimilars/news/ema-accepts-application-for-ustekinumab-biosimilar-avt04
6. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/Pharma-News/Korean-biosimilars-makers-pipelines-and-expansion
7. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. Trials of ustekinumab biosimilars advance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Trials-of-ustekinumab-biosimilars-advance

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