The U.S. Food and Drug Administration has approved Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab), for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis in patients aged 6 years and older, and moderately to severely active Crohn’s disease and ulcerative colitis in adults.
Starjemza is manufactured by Bio-Thera Solutions and will be commercialized in the U.S. by Hikma Pharmaceuticals under a licensing agreement that was initiated in August 2021.
The FDA’s approval was based on a comprehensive data package that included analytical, nonclinical, and clinical studies. Comparative analytical evaluations demonstrated structural and functional similarity between Starjemza and reference ustekinumab. A phase 1 trial assessed pharmacokinetics, safety, and immunogenicity in healthy volunteers, and a phase 3 trial evaluated efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. These studies demonstrated biosimilarity in clinical performance, including comparable efficacy and immunogenicity profiles.
Ustekinumab is a human monoclonal antibody that targets the p40 subunit, which is shared by interleukin-12 and interleukin-23—key cytokines in the Th1 and Th17 inflammatory pathways. By preventing the p40 subunit from binding to the IL-12Rβ1 receptor, Starjemza modulates downstream immune responses that are implicated in chronic inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Safety considerations include risks for serious infections, malignancies, hypersensitivity reactions including anaphylaxis, and rare cases of posterior reversible encephalopathy syndrome. Screening for latent tuberculosis and updating immunizations prior to therapy initiation is recommended. Starjemza should not be administered with live vaccines, and caution is warranted with household contacts receiving live vaccinations. Immunogenicity data indicate antidrug antibody development in a minority of patients, which may affect pharmacokinetics and therapeutic response.
According to Bio-Thera, Starjemza represents the company’s third FDA-approved biosimilar and supports broader access to biologic therapies.
Source: Hikma Pharmaceuticals