On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection. This approval makes Bio-Thera the seventh company to receive FDA approval for an ustekinumab biosimilar, joining Amgen, Alvotech, Samsung, Fresenius, Accord, Biocon, and Celltrion.
Ustekinumab 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-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. Abnormal regulation of IL-12 and IL-23 has been implicated as important contributor to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn’s disease (CD), and Ulcerative colitis (UC).
As we previously reported, in August 2021, Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA®. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product and Hikma is responsible for the commercialization of the product in the United States.
STARJEMZA® is Bio-Thera’s third biosimilar product approved by the FDA and Hikma’s first approved biosimilar