Biocon’s Subsidiary Launches New Biosimilar for Autoimmune Diseases

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has announced the launch of YESINTEK™ (ustekinumab-kfce) in the United States.

A Cost-Effective Biosimilar for Autoimmune Diseases

This marks a significant milestone for BBL as one of the first biosimilar alternatives to Stelara® (ustekinumab) in the U.S. market. YESINTEK is approved for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, providing a more cost-effective treatment option for patients with chronic autoimmune diseases.

It will be available in the same formulations as Stelara, including pre-filled syringes (PFS) and vials in multiple dosage strengths.

YESINTEK will have commercial payor coverage at launch and a comprehensive patient assistance program, offering copay support and benefits verification. Eligible patients may pay as little as $0 under the copay program, making the treatment more accessible.

The drug is a monoclonal antibody that inhibits IL-12 and IL-23 signalling, both of which are linked to immune-mediated diseases. Clinical studies confirmed that YESINTEK has comparable safety, efficacy, pharmacokinetics, and immunogenicity to Stelara.

FDA Approval and Market Expansion in the U.S.

With FDA approval granted in December 2024, Biocon Biologics aims to expand patient access to advanced biologic therapies while driving affordability in the U.S. healthcare market.

The CEO and Managing Director of Biocon Biologics Ltd, Shreehas Tambe, said, “The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organisation. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population.”

Laura Wingate, Chief Education, Support & Advocacy Officer of the Crohn’s & Colitis Foundation, stated, “The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available.”

Conclusion

YESINTEK’s launch in the U.S. enhances access to affordable treatment for autoimmune diseases. With support programs, it offers a viable Stelara® alternative.

On February 25, 2025, Biocon share price opened at ₹324.05, touching the day’s high at ₹329.00, as of 10:56 AM on the NSE.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.