ARTICLE
11 November 2025

Hikma Launches Ustekinumab Biosimilar STARJEMZA

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Goodwin Procter LLP

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On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).
United States Food, Drugs, Healthcare, Life Sciences
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On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny). STARJEMZA references Janssen's STELARA, and is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Craig Boyd, commercial lead for the biosimilar, commented that "We are excited to launch our first biosimilar in the US."

As we previously reported, on May 22, 2025, STARJEMZA became the seventh ustekinumab biosimilar to gain FDA approval. While Hikma commercialized STARJEMZA in the United States, Bio-Thera developed and manufactured the product pursuant to an agreement entered into between the companies in August 2021.

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