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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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
