USFDA approves Biocon’s biosimilar for autoimmune diseases, YESINTEK, revolutionising treatments for inflammatory conditions like Crohn’s and psoriasis. This milestone underscores Biocon’s commitment to expanding access to high-quality, affordable biosimilars.
USFDA approves Biocon’s Biosimilar YESINTEK
Biocon Biologics Ltd (BBL), a subsidiary of Biocon, has announced the USFDA’s approval of YESINTEK (Ustekinumab-kfce). This biosimilar to Stelara (Ustekinumab) is developed to treat autoimmune diseases, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, highlighted the importance of this approval:
“Biocon Biologics is committed to science and innovation. YESINTEK allows us to be among the first to offer reliable, high-quality biosimilar options for U.S. patients, supporting our expanding immunology franchise.”
Biocon’s agreement to launch Biosimilar in the US
USFDA’s approval of Biocon’s biosimilar for autoimmune diseases follows a licensing agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson. Under this settlement, YESINTEK will be available in the U.S. market by February 2025.
Matthew Erick, Chief Commercial Officer for Advanced Markets at Biocon Biologics, remarked,
“This milestone demonstrates our commitment to affordable healthcare solutions for patients with inflammatory diseases while driving innovation in biosimilars.”
Biocon strengthens immunology portfolio
The approval of Biocon’s biosimilar for autoimmune diseases is a significant addition to its growing immunology portfolio. It reaffirms Biocon’s role as a leader in biosimilars, providing accessible and life-changing treatments for complex medical conditions.
This development positions Biocon Biologics as a key player in the global healthcare market, continuing its mission to make advanced therapies accessible to patients worldwide.
