In a significant step for India’s biopharmaceutical innovation on the global stage, Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has secured expansive market access coverage for its biosimilar ustekinumab, marketed as Yesintek™ (ustekinumab-kfce), in the United States. This development marks a major commercial breakthrough for the company, with the product now covered across health plans representing over 100 million insured lives — a sizeable portion of the U.S. population.

This achievement not only reflects the robust capabilities of Biocon Biologics in the biosimilars space but also signifies a moment of pride for the Indian pharmaceutical sector, which is increasingly being recognised for its contributions to affordable biologic therapies worldwide.

Multiple U.S. Formularies Opt-In for Yesintek™

Yesintek™ has been included in the formularies of several major U.S. pharmacy benefit managers (PBMs) and insurers. Notably, Express Scripts will add the biosimilar to its National Preferred Formulary starting March 21, 2025, while Cigna will follow suit on the same date for its commercial plans.

Further expanding its reach, UnitedHealthcare has committed to including Yesintek™ in multiple segments of its healthcare plans. The biosimilar will be covered under UnitedHealthcare’s commercial plans starting May 1, 2025, followed by Managed Medicaid plans from March 1, 2025, and Medicare plans beginning June 1, 2025. This tiered rollout ensures broad and progressive access across key population groups in the U.S., reinforcing confidence in the biosimilar’s clinical and economic value.

CVS Health and Optum Rx have also added Yesintek™ to their formularies effective July 1, 2025.

Beyond national payers, the biosimilar has been included in regional health plan formularies such as Navitus, Costco Health Solutions, MedImpact, Priority Health, and UPMC. Importantly, Blue Cross Blue Shield of Michigan and Florida Healthcare Plan have designated Yesintek™ as their exclusive ustekinumab product, a move that underscores growing confidence in Biocon’s biosimilar offerings.

Biocon’s Strategic Entry into U.S. Biosimilar Market

Yesintek™ is Biocon Biologics’ first biosimilar product launched in the U.S. as a fully integrated company. It is a biosimilar to Stelara® (ustekinumab), a monoclonal antibody used for treating chronic immune-mediated conditions such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The product has received U.S. FDA approval in December 2024, with clinical studies affirming its comparable efficacy, safety, and immunogenicity to the reference biologic. It is available in multiple presentations: 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial, matching the formats currently offered by the originator product.

Shreehas Tambe, CEO & MD of Biocon Biologics, emphasised the broader implications of this milestone “Yesintek™ reflects our commitment to deliver science-driven, high-quality, affordable therapies to global markets. Securing placement on multiple U.S. formularies underscores the confidence healthcare payers have in our capabilities—from R&D to supply chain reliability.”

Josh Salsi, Head of North America, Biocon Biologics Inc., noted, “Yesintek™ is now covered for over 100 million Americans, which is nearly 70-80% of the commercial market. This is a significant advancement in making biosimilars more accessible to U.S. patients and aligns with our global mission to increase access to affordable biologic care.”

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Implications for India’s Biopharma Ecosystem

This development has far-reaching implications for India’s role in the global biosimilars market, especially as countries push to manage healthcare costs with high-quality, cost-effective alternatives. The success of Yesintek™ reinforces India’s position as a credible supplier of complex biologics and reflects the maturity of its regulatory and manufacturing ecosystems.

For Indian pharma companies eyeing regulated markets, this validates the go-to-market model of integrating science, quality, and market access strategy. It also underlines the critical importance of partnering with U.S. payers and pharmacy benefit managers to ensure biosimilar adoption at scale.

With Yesintek™, Biocon Biologics has not just launched a product—it has opened a new chapter for Indian biopharma on the global biosimilar map. As more Indian companies venture into regulated markets, this serves as both a benchmark and a bold statement of what is possible through innovation, integration, and strategic vision.

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