Ustekinumab-hmny: FDA Approves Stelara Biosimilar
- The Food and Drug Administration has given the green light to Starjemza (ustekinumab-hmny) injection, a biosimilar referencing Stelara (ustekinumab), according to Bio-Thera Solutions and Hikma Pharmaceuticals.
- The FDA's decision hinged on complete non-clinical and clinical data.
- A phase 3 clinical trial involving 278 patients with moderate to severe plaque psoriasis confirmed Starjemza's effectiveness.
The FDA has approved Starjemza (ustekinumab-hmny), a new ustekinumab biosimilar referencing Stelara, offering a fresh treatment option for those battling inflammatory conditions. This decisive move by the FDA, based on thorough clinical data, confirms StarjemzaS comparable efficacy, safety, and quality to its reference product. Both target IL-12 and IL-23, crucial elements in immune responses, providing crucial relief. A phase 3 trial showcased Starjemza’s effectiveness in treating moderate to severe plaque psoriasis, achieving similar results to Stelara, ensuring the same benefit for patients. News Directory 3 is following this vital progress closely. Explore the implications of this approval for patients and what this means for advancements in treatment options. Discover what’s next …
FDA Approves Starjemza, an Ustekinumab Biosimilar, for Inflammatory Conditions
The Food and Drug Administration has given the green light to Starjemza (ustekinumab-hmny) injection, a biosimilar referencing Stelara (ustekinumab), according to Bio-Thera Solutions and Hikma Pharmaceuticals. This approval introduces another option for patients needing ustekinumab treatment.
The FDA’s decision hinged on complete non-clinical and clinical data. These data demonstrated that Starjemza mirrors Stelara in efficacy, safety, immunogenicity, and overall quality. Both drugs target IL-12 and IL-23, key components in inflammatory and immune responses.
A phase 3 clinical trial involving 278 patients with moderate to severe plaque psoriasis confirmed Starjemza’s effectiveness. The study, which compared Starjemza (formerly known as BAT2206) to reference ustekinumab, showed comparable results in reducing the Psoriasis Area and Severity Index score. Researchers determined BAT2206 to be similar to stelara.
Another phase 1 trial assessed immunogenicity and safety in healthy Chinese males. The results indicated that BAT2206 exhibited similar pharmacokinetic effects and adverse event rates as reference ustekinumab sourced from both the U.S. and the European Union.
“This approval was based on a series of non-clinical and clinical data submitted to the FDA that indicates similar efficacy, safety, immunogenicity, and quality between Starjemza and Stelara,” Bio-Thera Solutions and Hikma Pharmaceuticals said in a joint statement.
What’s next
With the approval of Starjemza, the FDA continues to broaden the array of treatment choices for individuals grappling with immune-related ailments.While Starjemza is approved as a biosimilar, it is not yet designated as interchangeable. Patients should consult thier health care provider before using Starjemza.