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BioFactura Publishes Phase 1 Data on its Ustekinumab Biosimilar

Frederick, Maryland, September 11, 2023:  BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) (Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon et al; Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1Trial. Clinical Pharmacology, in Drug Development, 2023, 0(0) 1–12).

Pairwise comparisons among the 3 treatments all met the standard bioequivalence criteria that the 90% confidence interval of the geometric mean ratios of AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration are completely within the acceptance interval of 80.00%–125.00%. There were no marked differences in the safety, immunogenicity, and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups. There was no marked difference in the overall incidence of injection site reactions after dosing among treatment groups.  https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1305

This successful pivotal study paves the way to conduct a global efficacy and safety trial in in adult male and female subjects with moderate to severe plaque psoriasis, due to start early 2024.

Commenting on the development, Rodeina Challand, VP Scientific affairs said: “This is a critical milestone in the development of a biosimilar candidate for Stelara. Comparative PK studies are considered pivotal for demonstrating biosimilarity between the biosimilar candidate and the reference product”.

Jeffrey Hausfeld MD, MBA, Chief Medical Officer, and Chairman of the Board stated: “Being part of the cadre of physicians that introduced the adoption of generics from branded small molecule drugs in the 1980’s has provided me with a clear perspective of the controversies and trajectory of acceptance of biosimilars in the marketplace by patients, payors and physicians. While all stakeholders work through the debates of the need and benefits of interchangeable switching studies, and large Phase 3 safety and efficacy trials for biosimilar regulatory approvals, BioFactura will continue to focus on the development of high quality and reasonably priced biosimilar products to add value and improved outcomes for patients around the globe.”

On July 10, 2023, BioFactura, Inc. announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive global license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).

September 11, 2023 Press Releases
About BioFactura

BioFactura (Frederick MD) develops and commercializes high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast Biomanufacturing Platform, the optimal system for bringing these drugs to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.