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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.
Top 5 Most-Read Rheumatology Articles of 2024
December 30th 2024The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.
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.
Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17
December 14th 2024A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
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.
Similar Persistence Rates Between Adalimumab New Starts, Switched Patients
December 7th 2024A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.
Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis
December 3rd 2024The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.
