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Biodefense Company Steps Into Biosimilars Market
BioFactura has specialized in biodefense agents for smallpox and Marburg virus, but sees revenue potential in biosimilars.
Frederick, Maryland–based BioFactura has begun a phase 1 clinical trial for an ustekinumab biosimilar candidate (BFI-751). The prospective biosimilar references Stelara (Janssen Biotech), an immunosuppressant for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
The phase 1 trial will compare the pharmacokinetics of BFI-751 with US and EU versions of Stelara following a single subcutaneous dose administered to healthy volunteers. The randomized, double-blind study will assess safety, tolerability, and immune response.
“The first 3 sentinel groups have been dosed with no significant adverse events reported to date,” BioFactura said in a statement. The study will continue with the opening of clinical sites in Adelaide and Brisbane, Australia, and Auckland, New Zealand.
Darryl Sampey, PhD, president and CEO, said this is BioFactura’s first biosimilar clinical trial. Previously, the company has worked on biodefense, such as engineering drugs for emergency treatment of smallpox and Marburg virus (related to Ebola) outbreaks. Janssen reported $5.24 billion in Stelara revenues in 2020, up from $4.35 billion the year before.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists
June 5th 2025Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
