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The approval of STARJEMZA was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA.
May 27, 2025
By: Charlie Sternberg
Associate Editor
The U.S. Food and Drug Administration (FDA) has approved STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. Bio-Thera and Hikma entered into 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. “The approval of STARJEMZA is ano...
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