US FDA approves Biocon Biologics’ YESINTEK for autoimmune diseases

US FDA approves Biocon Biologics’ YESINTEK for autoimmune diseases

Biocon Biologics has announced that the US Food and Drug Administration (FDA) has approved YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

YESINTEK works by targeting specific proteins that contribute to inflammation, offering a new treatment option for patients with these chronic autoimmune diseases.

The approval is expected to provide an alternative for patients who require effective therapies for managing these conditions.


As part of a licensing agreement, Biocon Biologics has partnered with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson to commercialize YESINTEK in the U.S. market.

The agreement, which was initially announced on February 29, 2024, sets a target for commercialisation no later than February 22, 2025, pending FDA approval.

The FDA approval is a key step in Biocon Biologics’ strategy to expand its presence in the US market. The collaboration with Janssen, a global leader in healthcare, will help accelerate the commercialisation process and ensure broader access to YESINTEK for patients in need of these treatments.

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