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 another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer,” said Shengfeng Li, CEO at Bio-Thera. “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 U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients,” said Dr. Bill Larkins, President of Hikma Injectables. “Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. 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 known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between STARJEMZA and US and EU Stelara was conducted on structural, physicochemical, and biological properties to support bio-similarity of STARJEMZA. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA with both the US and EU Stelara in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA with Stelara for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The totality of the evidence demonstrated that STARJEMZA has similar efficacy, safety, immunogenicity, and quality as the reference product ustekinumab.