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BioFactura’s Biosimilar Ustekinumab, Demonstrates Pharmacokinetic (PK) Bioequivalence to Stelara® in Phase 1 Study
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BioFactura, Inc.
October 13, 2022, 13:03 GMT
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• Phase 1 clinical study demonstrated PK bioequivalence and comparable safety and immunogenicity profiles between BFI-751 and reference Stelara®.
meeting the primary endpoint of clinical bioequivalence in this trial, along with our bioanalytical comparative data, puts BFI-751 on the way to regulatory approval and commercial launch.”— Jeffrey N. Hausfeld MD, MBAFREDERICK, MARYLAND, UNITED STATES, October 13, 2022 /EINPresswire.com/ — BioFactura Inc. has announced today the completion of the pivotal pharmacokinetic comparability clinical trial for its Ustekinumab Biosimilar (BFI-751). The clinical trial was conducted in two sites in Australia and one site in New Zealand. BioFactura developed BFI-751 using its proprietary NS0 host cell line-based StableFastTM Biomanufacturing Platform.
Ustekinumab is a targeted monoclonal antibody directed against the common p40 subunit of the naturally occurring proteins interleukin (IL)-12 and IL-23, which regulate the immune system. The reference product, Stelara ®, has been approved for the treatment of plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis and is projected to have global market sales at $10B in 2023 prior to patent expiry.
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