The Phase-3 study, which represents the final trial phase for human drugs, demonstrated that bUstekinumab is equivalent in efficacy, safety, immunogenicity, and other treatment parameters to the reference product, Ustekinumab (Stelara). This marks a significant step forward in making therapies more accessible to patients globally.

Elena Wolff-Holz, Global Head of Clinical Development at Biocon Biologics, said in a statement, “The positive results from this Phase 3 study reaffirm the quality and therapeutic equivalence of YESINTEK compared to the reference product, Ustekinumab. This milestone underscores our commitment to providing cost-effective, high-quality biosimilars to patients with chronic conditions like psoriasis, expanding access to critical treatments globally.”

Psoriasis is a chronic inflammatory and proliferative skin disorder that primarily affects the skin, nails, and joints. According to a 2016 study (the most recent available), the prevalence of the disease in India was approximately 2.8%. While the exact cause remains unclear, it is generally believed to result from an overactive immune system that produces too many skin cells, leading to inflamed, scaly skin. Genetics and environmental factors are thought to play a significant role in the disease's development.

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