FDA Approves STARJEMZA: A New Chapter in Biosimilar Therapy

Bio-Thera Solutions, a prominent biopharmaceutical firm based in Guangzhou, China, in conjunction with Hikma Pharmaceuticals, recently announced that the U.S. Food and Drug Administration (FDA) has granted its approval for STARJEMZA® (ustekinumab-hmny) injection. This product is a biosimilar that references the established medication STELARA® (ustekinumab) injection. This approval is a significant milestone, as STARJEMZA becomes Bio-Thera's third product to gain FDA approval, reinforcing its position as a leading player in the global biosimilar sector.

The collaboration between Bio-Thera and Hikma began with a licensing and commercialization agreement established in August 2021. Under this agreement, Bio-Thera has taken on the responsibility for development and manufacturing, while Hikma will handle marketing and sales within the United States. This arrangement positions both companies to capitalize on the burgeoning biosimilar market in the U.S.

Shengfeng Li, Bio-Thera's CEO, expressed pride in this milestone, emphasizing that STARJEMZA is indicative of the company's commitment to increasing the availability of essential therapies. "As our third FDA-approved biosimilar, STARJEMZA reflects our dedication to expanding access to improved treatment options for patients suffering from serious medical conditions," he stated.

Dr. Bill Larkins, President of Hikma Injectables, echoed this sentiment, noting that the partnership will facilitate a stronger entry into the U.S. biosimilar market. “We're excited to utilize our well-established commercial capabilities to launch STARJEMZA. This is vital in ensuring that more patients can gain access to effective therapies.”

The basis for STARJEMZA's FDA approval stems from a rigorous methodology involving comprehensive analytical, non-clinical, and clinical data. Bio-Thera provided evidence demonstrating the similarity of STARJEMZA to both the U.S. and EU version of STELARA® through detailed characterization of structural and biological properties. Importantly, a randomized, double-blind, parallel Phase III study highlighted STARJEMZA's efficacy, safety, and immunogenicity as comparable to the reference product for individuals suffering from moderate to severe plaque psoriasis.

STARJEMZA functions by inhibiting the activity of human interleukin-12 (IL-12) and interleukin-23 (IL-23) - key cytokines involved in immune and inflammatory responses. The product is indicated for treating various conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis in patients aged six years and older. Its mechanism involves preventing the shared p40 subunit from binding to specific receptors on immune cells, thereby regulating inflammatory pathways implicated in several autoimmune disorders.

Bio-Thera Solutions is hailed as an innovative leader in developing new therapeutic options aimed at treating severe unmet medical requirements, such as cancer and autoimmune diseases. Their pioneering efforts have already led to several other approved products in both domestic and international markets. With over 20 candidates in various stages of clinical trials, the company maintains a strong focus on immuno-oncology and targeted therapies, including antibody-drug conjugates.

Hikma Pharmaceuticals, a global presence in the generic and branded medication landscape, strives to enhance healthcare accessibility for millions worldwide. The company’s strategic positioning in the U.S. biosimilar market is enhanced by this recent approval, allowing it to serve hospitals and healthcare providers with high-quality alternatives to branded injectables.

The approval of STARJEMZA represents not only a win for Bio-Thera and Hikma but also a pivotal turn in improving patient access to effective treatments for chronic conditions. With expectations set high for the product's market entry, the companies are keen to see how STARJEMZA will support patients navigating their healthcare journeys. As biosimilars continue to gain traction in the pharmaceutical landscape, STARJEMZA underscores the potential for innovation and improved patient care through collaborative efforts in the biopharmaceutical sector.

Conclusion

STARJEMZA's FDA approval is a testament to the commitment of Bio-Thera Solutions and Hikma Pharmaceuticals towards patient-centered care, showcasing an important step in enriching therapeutic options within the realm of biosimilars. This development holds promise for patients seeking novel and effective solutions to their health challenges.