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Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial

Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon, Nathaniel Macapagal, Pam Bruce-Staskal, Christina Fiaschetti and Darryl B. Sampey. Clinical Pharmacology in Drug Development.  July 2023.

BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and ustekinumab reference products from the European Union and United States as well as similarity of the EU and US reference products.

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July 24, 2023 Publications
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.