Biocon Biologics Ltd (BBL) has received US Food and Drug Administration (FDA) approval for Yesintek, a biosimilar to Johnson & Johnson’s reference product Stelara.
This approval represents a major advancement for Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd.
Biosimilars are medicines that are similar to brand-name drugs, but are available at much lower prices, making them accessible to large segments of society who cannot afford brand-name drugs.
Yesintek, a monoclonal antibody, treats Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This development is expected to provide affordable access to high-quality biosimilars to millions of patients around the world.
As part of the settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, Biocon Biologics plans to commercialize Yesintek in the United States by February 22, 2025.
As a leading player in the biosimilar space, Biocon said in a February 2024 statement that it has a pipeline of 20 biosimilar assets across diabetes, oncology, immunology and other non-infectious diseases. Ta.
