FDA Approves STARJEMZA® Biosimilar by Bio-Thera Solutions and Hikma Pharmaceuticals

FDA Approval Marks Major Milestone for Bio-Thera and Hikma Pharmaceuticals

On May 27, 2025, Bio-Thera Solutions and Hikma Pharmaceuticals were thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted approval for STARJEMZA® (ustekinumab-hmny) Injection. This important milestone for the companies marks STARJEMZA® as a biosimilar to STELARA® (ustekinumab) Injection, enhancing treatment options for patients with autoimmune conditions.

Bio-Thera Solutions, established as a commercial-stage biopharmaceutical enterprise, has demonstrated its commitment to developing innovative biosimilars and therapeutic assets. STARJEMZA® represents their third product to achieve FDA approval, further solidifying their reputation in the competitive biopharmaceutical landscape.

In August 2021, Bio-Thera and Hikma Pharmaceuticals entered into a licensing and commercialization agreement that has now come to fruition with this approval. Under the agreement, Bio-Thera focuses on the product's development and manufacturing, while Hikma takes charge of bringing STARJEMZA® to market in the United States. Dr. Bill Larkins, President of Hikma Injectables, expressed excitement about this opportunity, highlighting Hikma's established position as a leading provider of sterile injectable medicines in U.S. healthcare settings.

Significance of STARJEMZA® Approval

The approval of STARJEMZA® underscores Bio-Thera's dedication to enhancing patient access to critical therapies. CEO Shengfeng Li praised the accomplishment, attributing it to the company's diligence and innovative spirit. As the U.S. market continues to grow for biosimilars, Hikma is committed to leveraging its robust commercial capabilities to ensure STARJEMZA® reaches the patients who can benefit from it.

The FDA's authorization is based on a comprehensive package of analytical, non-clinical, and clinical data submitted by Bio-Thera. The rigorous evaluation of STARJEMZA® included detailed comparisons to both U.S. and European versions of STELARA® concerning structural, physicochemical, and biological properties.

A randomized, double-blind, single-dose study evaluated STARJEMZA® against STELARA® in healthy volunteers, assessing pharmacokinetics, safety, and immunogenicity. Furthermore, a multicenter, randomized, double-blind, parallel-arm, phase III study focused on efficacy, safety, and immunogenicity in patients suffering from moderate to severe plaque psoriasis. The study's findings confirmed that STARJEMZA® exhibits comparable efficacy, safety, and immunogenicity to its reference product, further validating its substantial clinical integrity.

About STARJEMZA®

STARJEMZA® is designed to inhibit the bioactivity of the human IL-12 and IL-23 interleukins, which are recognized for their roles in immune responses and inflammation. By blocking these pathways, STARJEMZA® aims to provide therapeutic relief for conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, where chronic inflammation is a significant concern.

The strategic collaboration between Bio-Thera and Hikma marks a significant movement in the global biosimilar market. With an expansive portfolio of products and numerous candidates in clinical stages, Bio-Thera is eager to continue contributing to the field of biopharmaceuticals, particularly focusing on innovative therapies and successful biosimilars.

Company Insights

Bio-Thera Solutions, based in Guangzhou, China, is not just a leader in the biosimilar sector but also has a strong pipeline aimed at addressing several unmet medical needs. With approvals for various therapeutic agents, including QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection, the company showcases its ability to lead in monoclonal antibody research and development.

For Hikma Pharmaceuticals, this partnership represents a chance to deepen its footprint in the U.S. biosimilar market. With a commitment to quality and patient access, Hikma continues to strive towards improving healthcare outcomes through high-quality medicines that cater to diverse patient populations, thereby shaping a healthier global community.

Both companies remain optimistic about their future ventures, aiming to innovate and expand their offerings significantly. The approval of STARJEMZA® is not only a win for Bio-Thera and Hikma but, more importantly, for patients seeking effective treatment options for chronic inflammatory diseases.

For more details on STARJEMZA® and further updates from Bio-Thera and Hikma, please visit Bio-Thera and Hikma.