British pharmaceutical company Hikma Pharmaceuticals plc (LON:HIK), alongside its subsidiary Hikma Pharmaceuticals USA Inc and Chinese biotechnology company Bio-Thera Solutions Ltd (SHA:688177), announced on Tuesday that the US Food and Drug Administration (FDA) has approved STARJEMZA (ustekinumab-hmny) Injection, an immune disorder treatment jointly developed by Hikma and Bio-Thera.

STARJEMZA Injection is a biosimilar referencing Janssen Biotech Inc's Stelara (ustekinumab) Injection, used in the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

This marks the third FDA-approved biosimilar for Bio-Thera. FDA approval was based on a comprehensive data package, including analytical, non-clinical and clinical studies. STARJEMZA demonstrated comparable efficacy, safety and immunogenicity to Stelara in phase I and phase III trials.

Under their 2021 agreement, Bio-Thera handles development and manufacturing, while Hikma and its US subsidiary manage commercialisation efforts in the United States.

This milestone allows Hikma to leverage its established US injectables infrastructure to deliver STARJEMZA to patients who would benefit from this treatment.