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BioFactura Announces Commencement of Ustekinumab Biosimilar Phase 1 Trial


BFI-751, Biofactura’s biosimilar drug to ustekinumab will be investigated for the first time on human patients.

BioFactura, a leading developer of biosimilar and biodefense drugs, announced that start of the phase 1 clinical trial for its ustekinumab biosimilar (BFI-751) to assess the efficacy and safety compared to ustekinumab (Stelara; Janssen Biotech) and it is the first-time human patients will be receiving the treatment.1 

The study is a bioequivalence randomized, double-blind trial with 210 patients enrolled in both Australia and New Zealand, to compare the pharmacokinetics of BFI-751 to ustekinumab-US and Stelara-EU. Ustekinumab is an immunosuppressant used to treat Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The first 3 sentinel groups have received treatment and have reported no significant adverse events (AEs) to date, so the study has been extended to all 3 clinical sites. 

“As a physician, it is exhilarating to be part of the journey at BioFactura. From biopharmaceutical research and development to manufacturing and the initiation of this pivotal trial, it is clear how much progress has been made," said Jeffrey Hausfeld, MD, MBA, FACS, chairman of the board and chief medical officer of BioFactura, Inc.

Darryl Sampey, BioFactura’s president and CEO commented that this is the first of the biosimilar pipeline to come. 


1. BioFactura announces initiation of Phase I study of BFI-751, a Stelara® (Ustekinumab) biosimilar. PRWeb. Accessed July 26, 2021. https://www.prweb.com/releases/biofactura_announces_initiation_of_phase_i_study_of_bfi_751_a_stelara_ustekinumab_biosimilar/prweb17963481.htm

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