Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company, and Hikma Pharmaceuticals PLC, along with its U.S. subsidiary Hikma Pharmaceuticals USA Inc., have announced that the U.S. Food and Drug Administration (FDA) has approved Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab).
Starjemza is Bio-Thera’s third FDA-approved product.
The two companies entered into a license and commercialization agreement in August 2021:
“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.”
“This approval and our partnership with Bio-Thera enables us to strongly enter the US biosimilar market. Tapping into the robust ongoing growth of the US biosimilar market is a priority for Hikma... We are eager to use our excellent US commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it.”
The FDA approval of Starjemza (originally BAT2206) was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera.
The totality of evidence showed that Starjemza has similar efficacy, safety, immunogenicity, and quality compared to Stelara.
Starjemza is a biosimilar to Janssen’s Stelara, a human monoclonal antibody that inhibits the bioactivity of IL-12 and IL-23. It achieves this by:
IL-12 and IL-23 are involved in:
Their dysregulation is linked to chronic inflammatory diseases like:
By neutralizing IL-12 and IL-23, Starjemza helps block Th1 and Th17 cell signaling, potentially mitigating these immune disorders.
Bio-Thera, based in Guangzhou, China, is a leading global biopharmaceutical company focused on:
Hikma Pharmaceuticals has been delivering high-quality, accessible medicines for over 45 years.