Bio-Thera and Hikma Receive FDA Approval for STARJEMZA®, a Biosimilar to Stelara®
Tuesday, May 27, 2025
Bio-Thera Solutions Ltd, a commercial-stage biopharmaceutical company, and Hikma Pharmaceuticals PLC, including its US subsidiary, have received approval from the US Food and Drug Administration (FDA) for STARJEMZA® (ustekinumab-hmny) Injection. This medicine is a biosimilar to Stelara® (ustekinumab) Injection and marks Bio-Thera's third FDA-approved product.
The two companies signed a licensing and commercialisation agreement for STARJEMZA® in August 2021. Under this agreement, Bio-Thera is responsible for the development and manufacturing of the product, while Hikma will handle its commercialisation in the United States.
The FDA’s approval was based on a complete set of analytical, non-clinical, and clinical data. Bio-Thera provided comparative studies between STARJEMZA® and both the US and EU versions of Stelara®. These studies covered structural, physicochemical, and biological properties. A phase I trial assessed pharmacokinetics, safety, and immunogenicity in healthy volunteers, while a phase III study evaluated its safety, efficacy, and immunogenicity in patients with moderate to severe plaque psoriasis. The findings showed that STARJEMZA® matches the reference product in all major aspects.
STARJEMZA® is a biosimilar of Janssen’s Stelara®, a monoclonal antibody that targets IL-12 and IL-23 by blocking their shared p40 subunit from binding to receptor complexes on immune cells. These interleukins play a role in immune system regulation and are linked to several chronic inflammatory conditions. By neutralising these targets, STARJEMZA® helps to interrupt the inflammatory pathways associated with diseases such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The approval supports both companies’ goals of expanding patient access to biologic therapies and strengthens their presence in the growing US biosimilar market.
Source: prnewswire.com
