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Aurobindo's subsidiary CuraTeQ obtains exclusive rights for BioFactura's Ustekinumab biosimilar
IMT News Desk
1 year ago
Aurobindo’s subsidiary CuraTeQ obtains exclusive rights for BioFactura’s Ustekinumab biosimilar
IMT News Desk
1 year ago
CuraTeQ has been granted exclusive license rights to commercialize BFI-751 in all major regulated markets including the US, the EU, the UK, Canada, ANZ and certain other semi-regulated and emerging markets worldwide
Aurobindo Pharma has announced that CuraTeQ Biologics, its wholly owned subsidiary, has entered into an exclusive license agreement with the US-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.
Under the terms of the agreement, CuraTeQ has been granted exclusive license rights to commercialize BFI-751 in all major regulated markets including the US, the EU, the UK, Canada, ANZ and certain other semi-regulated and emerging markets worldwide. Additionally, CuraTeQ will have 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 2024 and the regulated markets filing is expected to begin in 2026.
Dr Satakarni Makkapati, CEO, Biologics, Vaccines and Peptides, Aurobindo Pharma said, "BioFactura has demonstrated bio-equivalence of BFI-751 vs US and EU registered originator product Stelara in a three-arm Phase 1 study conducted in 200 plus healthy subjects. We are excited by the prospect of this Ustekinumab biosimilar advancing to Phase 3 clinical studies in the due course of time. Ustekinumab fits into our expanding immunology products portfolio very well and we will use our presence across key markets to commercialise this product."
Nithyananda Reddy, MD and Vice Chairman, Aurobindo Pharma said, "This agreement underscores our investment intentions in the biosimilars business. It is our commitment to improve the lives of patients suffering from these debilitating immune and inflammatory diseases by delivering them access to cost-effective and high-quality biosimilars such as Ustekinumab."
Darryl Sampey, President and CEO, BioFactura said, "The development of our BFI-751 biosimilar to Stelara has been an all-encompassing endeavour at BioFactura which led to the impressive clinical results of our pivotal bio-comparability trial. With CuraTeQ, we have found the optimal partner to complete the journey and bring this important product to market."