Biocon Biologics Receives US FDA Nod For Yesintek, A Biosimilar To J&J's Stelara

Biocon Biologics Ltd. has received US Food and Drug Administration approval for Yesintek, a biosimilar for Johnson & Johnson's reference product, Stelara.

This approval marks a major breakthrough for Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd.

Biosimilars are medicines similar to original medicines but available at a far lower price to make them accessible to large section of society who cannot afford the original medicines.

Yesintek, a monoclonal antibody, will treat Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This development is expected to provide affordable access to high-quality biosimilars for millions of patients worldwide.

As part of its settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, Biocon Biologics is set to commercialise Yesintek in United States by Feb. 22, 2025.

As a leading player in the biosimilars space, Biocon has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases, it said in a statement in February 2024.