Biocon Secures FDA Approval for Innovative Autoimmune Drug YESINTEK

1 Dec 2024 , 11:20 PM

Biocon Biologics has received the FDA nod for YESINTEK, a monoclonal antibody to treat conditions such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. YESINTEK targets specific proteins that trigger inflammation, which presents new therapeutic options in the chronic management of autoimmune diseases.

The approval offers a much better alternative for patients in need of advanced treatment for these diseases. Biocon Biologics has entered into a licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson for the commercialization of the drug in the U.S. market.

The licensing agreement was announced on February 29, 2024, and sets the date for commercialization at February 22, 2025, post-FDA approval. This deal further strengthens Biocon Biologics’ strategy to expand its footprint in the U.S. healthcare market.

Collaboration with Janssen, a leading global healthcare player, aims to fast-track the launch and enhance accessibility to YESINTEK for patients in need. Biocon Biologics has always led the innovation in healthcare solutions, and this nod from the FDA is another step forward towards the unmet patient needs in relation to autoimmune diseases.