Request Demo
FDA Approves Biocon's YESINTEK™ Biosimilar to Stelara®
6 December 2024
BENGALURU, Karnataka, India I December 01, 2024 I
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce). YESINTEK™ is a biosimilar to Stelara® (Ustekinumab) and is a monoclonal antibody designed to treat several inflammatory conditions. These conditions include Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis, and Psoriatic Arthritis.
In a prior notification to the Stock Exchange on February 29, 2024, Biocon Biologics Ltd had disclosed that it had formed a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson. This agreement allows Biocon Biologics to commercialize YESINTEK™ in the United States by February 22, 2025, following FDA approval.
The approval of YESINTEK™ represents a significant development in the field of biosimilars, providing an alternative treatment option for patients with these chronic conditions. This development is poised to enhance the accessibility and affordability of biologic therapies in the United States healthcare system.
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce). YESINTEK™ is a biosimilar to Stelara® (Ustekinumab) and is a monoclonal antibody designed to treat several inflammatory conditions. These conditions include Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis, and Psoriatic Arthritis.
In a prior notification to the Stock Exchange on February 29, 2024, Biocon Biologics Ltd had disclosed that it had formed a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson. This agreement allows Biocon Biologics to commercialize YESINTEK™ in the United States by February 22, 2025, following FDA approval.
The approval of YESINTEK™ represents a significant development in the field of biosimilars, providing an alternative treatment option for patients with these chronic conditions. This development is poised to enhance the accessibility and affordability of biologic therapies in the United States healthcare system.
How to obtain the latest research advancements in the field of biopharmaceuticals?
In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.