Aurobindo Pharma arm CuraTeQ Biologics to commercialize proposed biosimilar to Stelara
CuraTeQ intends to file this product in India and Emerging Markets as early as in 2024 and the regulated markets filing is expected to begin in 2026.;
Hyderabad: Aurobindo Pharma Limited has announced that CuraTeQ Biologics Private Limited, its wholly owned subsidiary, has entered into an exclusive license agreement with the USA based BioFactura to commercialize BFI-751, a proposed biosimilar to Stelara (Ustekinumab).
Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used for treating Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The global drug sales of Ustekinumab stood at close to 10 billion in 2022 presenting a significant opportunity with a good number of indications and a wider use.
Under the terms of the agreement, CuraTeQ have been granted exclusive license rights to commercialize BFI-751 in all major regulated markets including US, EU, UK, Canada, ANZ and certain other semiregulated and emerging markets worldwide. Additionally, CuraTeQ will have the global manufacturing rights for this product, which will be produced at CuraTeQ facilities in Hyderabad, India.
BioFactura plans to begin a global Phase 3 trial of the product as the next logical milestone in development. CuraTeQ intends to file this product in India and Emerging Markets as early as in 2024 and the regulated markets filing is expected to begin in 2026.
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