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).
About BioFactura, Inc. BioFactura, Inc. (Frederick MD) develops and commercializes high-value biodefense medical countermeasures and 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 15 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.
Media Contact
Jeffrey Hausfeld MD, MBA, BioFactura, 301-792-8601, [email protected], www.biofactura.com
SOURCE BioFactura
