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CuraTeQ Biologics enters into exclusive licence agreement with BioFactura, Inc to commercialise its biosimilar to Janssen’s Stelara® (ustekinumab)

Jul 7, 2023

Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license agreement with the USA-based BioFactura Inc, to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara® (ustekinumab).  Ustekinumab is a recombinant monoclonal antibody for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Under the terms of the agreement, CuraTeQ has exclusive license rights to commercialise BFI-751 in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ as well as in certain other markets, and the global manufacturing rights.  The product will be produced at CuraTeQ facilities in Hyderabad, India.  BioFactura has plans to begin a global Phase 3 trial of the product.  CuraTeQ intends to file the product in India and ‘emerging markets’ as early as 2024 and in the regulated markets beginning in 2026.