Aurobindo Pharma subsidiary CuraTeQ Biologics has entered into an exclusive license agreement with U.S. firm BioFactura Inc to commercialise BFI-751, a proposed biosimilar to recombinant monoclonal antibody Stelara (Ustekinumab) that is used for treating Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Global sales of Stelara (Ustekinumab) was about $9.72 billion in 2022, Aurobindo said announcing the agreement under which CuraTeQ will commercialise the biosimilar on an exclusive license right basis in all major regulated markets, including the U.S., EU and the U.K. and certain other semi-regulated and emerging markets worldwide.
Additionally, CuraTeQ will have the global manufacturing rights for the product, which will be produced at its facilities in Hyderabad. CuraTeQ intends to file this product in India and Emerging Markets as early as in 2024. The regulated markets filing is expected to begin in 2026.
BioFactura plans to begin a global Phase 3 trial of the product. It will receive licence fees not exceeding $33.5 million spread across different milestones leading to commercialisation in regulated markets, the drugmaker said.
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