USFDA approves Biocon Biologics' biosimilar for Crohn's disease, psoriasis

Biocon’s arm, Biocon Biologics Ltd (BBL), announced today that the US Food and Drug Administration (USFDA) has approved YESINTEK (Ustekinumab-kfce), a biosimilar to the reference product Stelara (Ustekinumab), according to a company filing.

 

YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

 

Shreehas Tambe, chief executive officer and managing director of Biocon Biologics, said, “This settlement agreement reflects our commitment and focus on science and innovation. We are pleased that this allows Biocon Biologics to be among the first to offer a reliable, high-quality biosimilar option to patients and healthcare providers in the United States with our bUstekinumab, Bmab 1200. This development enables Biocon Biologics to build further on our existing immunology franchise in the US. As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products.”

 

Biocon Biologics had previously notified the stock exchange in February 2024 that the company had entered into a settlement and licensing agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialise YESINTEK in the United States no later than February 2025, upon approval from the USFDA.

 

Matthew Erick, chief commercial officer for advanced markets at Biocon Biologics, noted that the agreement is an important milestone in the company’s commitment to delivering affordable, life-changing biosimilar medicines. “It underscores the company’s steadfast resolution to support the well-being of patients impacted by inflammatory diseases and drive positive change within the healthcare industry,” Erick added.