Aurobindo Pharma subsidiary CuraTeQ Biologics has entered into an unique license settlement with U.S. agency BioFactura Inc to commercialise BFI-751, a proposed biosimilar to recombinant monoclonal antibody Stelara (Ustekinumab) that’s used for treating Crohn’s illness, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Global gross sales of Stelara (Ustekinumab) was about $9.72 billion in 2022, Aurobindo stated saying the settlement underneath which CuraTeQ will commercialise the biosimilar on an unique license proper foundation in all main regulated markets, together with the U.S., EU and the U.Ok. and sure different semi-regulated and rising markets worldwide.
Additionally, CuraTeQ could have the worldwide manufacturing rights for the product, which will likely be produced at its services in Hyderabad. CuraTeQ intends to file this product in India and Emerging Markets as early as in 2024. The regulated markets submitting is anticipated to start in 2026.
BioFactura plans to start a worldwide Phase 3 trial of the product. It will obtain licence charges not exceeding $33.5 million unfold throughout totally different milestones main to commercialisation in regulated markets, the drugmaker stated.
