Biocon Biologics Ltd. (BBL), a leading global biosimilars company and subsidiary of Biocon Ltd, has achieved a major milestone with its biosimilar Yesintek™ (ustekinumab-kfce) gaining broad formulary coverage in the United States. This development significantly enhances the company’s presence in the largest pharmaceutical market in the world.

The biosimilar is a therapeutic equivalent to Stelara®, a treatment used widely for chronic autoimmune diseases like Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Yesintek is the first product Biocon Biologics has launched in the US as a fully integrated biosimilars company, symbolizing a strong entry into the North American market.

Yesintek™ Secures Market Access Covering Over 100 Million Lives

Yesintek™ has been added to the formularies of major US pharmacy benefit managers (PBMs) and health insurers, securing access to over 100 million covered lives. This covers 70%-80% of the commercial US health market, ensuring that a significant portion of the American population can now access this cost-effective alternative.

Key players adding Yesintek™ to their formularies include:

• Express Scripts (National Preferred Formulary) – Effective March 21, 2025

• Cigna – Commercial formulary – Effective March 21, 2025

• UnitedHealthcare – Commercial from May 1, 2025, Medicaid from March 1, 2025, Medicare from June 1, 2025

• CVS Health – Coverage from July 1, 2025

• Optum Rx – Premium and Select formularies from July 1, 2025

Other healthcare entities including Navitus, MedImpact, Priority Health, and University of Pittsburgh Medical Center (UPMC) have also listed the biosimilar. Importantly, Blue Cross Blue Shield of Michigan (BCBSM) and Florida Healthcare Plan have selected Yesintek™ as the exclusive ustekinumab product.

A Step Forward in Access to Affordable Biosimilars

According to Shreehas Tambe, CEO & MD of Biocon Biologics, this development demonstrates the growing trust of US payors in Biocon’s scientific expertise, supply chain reliability, and commercial competence. The widespread adoption of Yesintek™ also validates the US healthcare system’s intent to broaden access to affordable treatment options through biosimilars.

Josh Salsi, Head of North America at Biocon Biologics Inc., added that more than 100 million Americans now have access to Yesintek™, highlighting the role of biosimilars in reshaping cost-effective healthcare for chronic diseases.

Formulations and Indications of Yesintek™

Yesintek™ mirrors the reference drug Stelara® in terms of formulation and clinical indications. It is available in the following formats:

• 45 mg/0.5 mL Prefilled Syringe (PFS)

• 90 mg/mL PFS

• 45 mg/0.5 mL vial

• 130 mg/26 mL vial

The drug is approved for use in treating:

• Crohn’s disease

• Ulcerative colitis

• Plaque psoriasis

• Psoriatic arthritis

These are chronic autoimmune diseases that require long-term treatment strategies, and Yesintek™ offers a cost-effective and accessible alternative to the innovator product.

Why This Matters in the Broader Healthcare Landscape

Biocon Biologics’ success in the US formulary market highlights the increasing acceptance of biosimilars as safe, effective, and affordable treatment options. Given the rising cost of biologics in the US, biosimilars like Yesintek™ provide relief to the healthcare system and patients alike.

This development also strengthens India's position as a trusted manufacturer of high-quality biopharmaceuticals, as Biocon Biologics represents Indian innovation on the global stage. As US insurers focus more on reducing drug expenditure, strategic partnerships with biosimilar makers like Biocon are likely to increase.

Strategic Significance for Biocon Biologics

The success of Yesintek™ is more than just a commercial win—it marks:

• Biocon’s evolution into a fully integrated biosimilars powerhouse

• Validation of its clinical manufacturing and regulatory capabilities

• Increased leverage in negotiating future formulary placements in other geographies

It also lays the foundation for future biosimilar launches in the United States, strengthening Biocon’s pipeline and market strategy.

Future Outlook and Industry Implications

Biocon Biologics is currently finalizing additional formulary agreements with other US commercial payors, signaling that the coverage may increase further. The success of Yesintek™ can be seen as a benchmark for future biosimilars launched by Indian companies in the global market.

The broader impact is clear:

• Improved patient access

• Reduced drug spending for healthcare systems

• Greater competitive pressure on reference biologic manufacturers

Conclusion

Biocon Biologics’ achievement in securing formulary coverage for Yesintek™ across the US is a landmark moment in the biosimilars space. It sets a new precedent for Indian pharmaceutical innovation and global healthcare collaboration.

With a robust biosimilar pipeline and increasing global partnerships, Biocon Biologics is poised to become a leader in accessible biologic therapies. The successful launch of Yesintek™ reaffirms its commitment to making high-quality treatments affordable and available across the world.

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