July 2023 – BioFactura

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 … Continue reading

July 24, 2023 BioFactura Publications

Lee Seeks Increased Competition in Biological Drug Market

From Mike Lee U.S. Senator of Utah July 13, 2023, WASHINGTON – Sens. Mike Lee (R-UT), Ben Ray Luján (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduced the Biosimilar Red Tape Elimination Act to increase competition within the biological drug market and increase access to low-cost prescription drugs. <Read Full Article&gt… Continue reading

July 14, 2023 BioFactura In The News

BioFactura and CuraTeQ Sign Exclusive License for BFI-751—A Biosimilar to Stelara

Frederick, Maryland, July 10, 2023: BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used … Continue reading

July 10, 2023 BioFactura Press Releases

Monthly Archives: July 2023

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

Lee Seeks Increased Competition in Biological Drug Market

BioFactura and CuraTeQ Sign Exclusive License for BFI-751—A Biosimilar to Stelara