FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara
Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.
The FDA approved ustekinumab-hmny (Starjemza) as a biosimilar referencing ustekinumab (Stelara). Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.1,2
Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease. | Image Credit: B-design - stock.adobe.com
"The approval of Starjemza is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer," Shengfeng Li, CEO at Bio-Thera, said in a news release.1 "As our third FDA-approved biosimilar, Starjemza demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies."
The FDA approval was based on a nonclinical and clinical package submitted to the agency. In a randomized, double-blind, parallel phase 1 study, investigators analyzed the pharmacokinetics, safety, and immunogenicity of the drug compared to the US and EU Stelara formulations. In a phase 3 study, investigators compared the biosimilar and reference product for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.1
In the phase 1 study, investigators included 270 healthy male individuals aged 18 to 55 years with a body weight between 55 and 85 kg. Patients received 1 of the 3 treatments, and 266 completed the study. There were 90 patients that received the biosimilar, 88 that received the US Stelara formulation, and 88 that received the EU formulation.3
“There were no deaths, serious AEs [adverse events], or discontinuations due to treatment-emergent AEs (TEAEs). A total of 425 clinical TEAEs were reported in 186 (69.1%) subjects with medication administration, including 63 (70.0%) subjects in the BAT2206 group, 63 (70.8%) subjects in the ustekinumab (EU) group, and 60 (66.7%) subjects in the ustekinumab (USA) group,” the study investigators stated.3
They added that TEAEs were similar across the groups, with the most frequent being hypertriglyceridemia, hyperglycemia, elevated alanine aminotransferase, elevated neutrophil count, decreased neutrophil count, elevated white blood cell count, elevated hemobilirubin, and hematuria. As for pharmacokinetics, the mean serum concentration-time profile had similar trends.3
In the phase 3 study, investigators randomized treatment 1:1 for 45 mg or 90 mg of the biosimilar or the reference product, with 278 patients being treated until week 28. The primary end point included the percentage change from baseline in Psoriasis Area and Severity Index score to week 8 or 12. The secondary end points included safety, pharmacokinetics, and immunogenicity, according to the study authors.4
Investigators found that the least squares mean difference for the primary end point was 0.964 at week 8 and 1.774 at week 12, demonstrating comparable results for the biosimilar and the reference product. Investigators found similar results for the secondary end points.4
READ MORE: Biosimilars Resource Center
Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.
