Bio-Thera And Hikma Win FDA Approval For STARJEMZA®, A Stelara® Biosimilar For Inflammatory Diseases

Bio-Thera Solutions and Hikma Pharmaceuticals announced that the FDA has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar to Stelara®. This marks Bio-Thera’s third FDA-approved product. STARJEMZA® is indicated for the treatment of immune-mediated inflammatory diseases and was developed by Bio-Thera and will be commercialised in the U.S. by Hikma under a 2021 licensing agreement.

“The approval of STARJEMZA® is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer. As our third FDA-approved biosimilar, STARJEMZA® demonstrates Bio-Thera’s commitment to developing more biosimilars, expanding patient access to important therapies,” said Shengfeng Li, CEO at Bio-Thera.

The FDA approval was supported by strong data, including extensive analytical, non-clinical, and clinical studies. These studies confirmed the biosimilarity of STARJEMZA® to both U.S. and EU-sourced Stelara®, particularly in terms of structure, function, safety, and efficacy. A Phase I trial demonstrated comparable pharmacokinetics and immunogenicity, while a Phase III trial in patients with moderate to severe plaque psoriasis confirmed similar efficacy and safety profiles. 

“This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients. Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it,” said Dr. Bill Larkins, President of Hikma Injectables. 

This approval reinforces Bio-Thera’s growing footprint in the biosimilar market and strengthens Hikma’s U.S. portfolio. STARJEMZA® provides a new, potentially cost-effective treatment option for patients, contributing to broader access to biologic therapies in the U.S. market. The launch timing and pricing of STARJEMZA® will be subject to market entry agreements and ongoing commercial planning.