Bio-Thera Solutions Ltd and Hikma Pharmaceuticals PLC announced that the U.S. Food and Drug Administration has approved STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. STARJEMZA is Bio-Thera's third FDA approved product.
Bio-Thera and Hikma reached a license and commercialization agreement for STARJEMZA in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA in the United States.
STARJEMZA is a biosimilar to Janssen's Stelara which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rß1 receptor chain of IL-12 (IL-12Rß1/ß2) and IL-23 (IL-12Rß1/23R) receptor complexes on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release.
Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), and Ulcerative colitis (UC).
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