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ustekinumab biosimilar BFI-751
- Development stage
- Phase 1
- Lead developer
- BioFactura
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous, Oral, Subcutaneous
01
Overview
BFI-751 is a proposed biosimilar to ustekinumab, a humanized monoclonal antibody that targets the p40 subunit shared by interleukin 12 (IL-12) and interleukin 23 (IL-23), thereby inhibiting their activity. Ustekinumab is an immunosuppressant used to treat inflammatory conditions such as Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. BFI-751 has been developed by BioFactura Australia as a biosimilar candidate to both EU and US reference products of Stelara (ustekinumab). The drug has undergone phase I clinical trials comparing its pharmacokinetics, safety, and immunogenicity with those of the reference product in healthy volunteers. Results demonstrated bioequivalence in pharmacokinetic parameters and similar safety profiles between BFI-751 and the originator product. BioFactura plans further global phase III trials for this candidate[1][2][3][4][5][7].
- Other names
- Stelara biosimilar
02
Targets
IL12B (Interleukin-12/23 p40 subunit)
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