Guangzhou and London – May 22, 2025 – Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) 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 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.
About STARJEMZA? (ustekinumab-hmny) Injection
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-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) 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). Neutralizing human IL-12 and IL-23 by STARJEMZA? to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI? (adalimumab) and BETAGRIN? (bevifibatide citrate) Injection in China, STARJEMZA? in the US, and BAT1806/TOFIDENCETM (tocilizumab) and AVZIVI? (bevacizumab-tnjn) in the US, a/k/a POBEVCY? in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.helizi.cn/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
About Hikma Pharmaceuticals
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to STARJEMZA?/BAT2206 or the product pipelines in general of Bio-Thera Solutions and Hikma. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and Hikma and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions and Hikma undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.
1) STARJEMZA? is a registered trademark of Hikma Pharmaceuticals USA Inc.
2) STELARA? is a registered trademark of Johnson and Johnson
3) QLETLI? is a registered trademark of Bio-Thera Solutions, Ltd.
4) BETAGRIN? is a registered trademark of Bio-Thera Solutions, Ltd.
5) TOFIDENCE? is a trademark of Organon LLC
6) AVZIVI? is a registered trademark of Sandoz
7) POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.
