1. Home
  2. Author: BioFactura

All posts by: BioFactura

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.

BioFactura Receives $7.8 Million in Funding for Contract Options for its Smallpox Biodefense Therapeutic

Frederick, Maryland, November 5, 2024:  BioFactura, Inc. recently announced contract option activations totaling $7.8 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, as part of BioFactura’s prime contract valued at up to $78 million for … Continue reading

November 5, 2024 Press Releases

BioFactura Funded $16 Million Contract Option for its Smallpox Biodefense Therapeutic

Frederick, Maryland, October 2, 2023:  BioFactura, Inc. today announced a contract option activation of over $16 million by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as part of its prime contract valued at over $77 million … Continue reading

October 2, 2023 Press Releases

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 … Continue reading

September 11, 2023 Press Releases

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 Publications

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 Press Releases

BioFactura Announces Activation of a $15.9M Contract Option for its Smallpox Biodefense Therapeutic

Frederick, Maryland, July 14, 2022:  BioFactura Inc. (“BioFactura”) today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox. This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the … Continue reading

July 14, 2022 Press Releases

BioFactura’s Ustekinumab Biosimilar To Be Trialed As ‘Robotic’ Pill

From Generics Bulletin/Informa Pharma Intelligence By Dean Rudge 14SEP2021 BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill. <Read Full Article&gt… Continue reading

September 14, 2021 In The News

BioFactura Announces MTA with Rani Therapeutics

Frederick, Maryland, September 9, 2021:  BioFactura Inc. (“BioFactura”), a leading developer of high-value biosimilar and biodefense drugs using its patented StableFast™ platform, announces an agreement with Rani Therapeutics (“Rani”) to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform.  BFI-751 is being developed by BioFactura Australia Pty Ltd, a subsidiary of BioFactura, as a biosimilar … Continue reading

September 9, 2021 Press Releases