Biocon Biologics Ltd. , a subsidiary of Biocon Limited, has announced a significant milestone in its US market penetration strategy. The company has secured multiple market access agreements for Yesintek™ (ustekinumab-kfce), its biosimilar to Stelara® (ustekinumab), covering over 100 million lives in the United States.

Broad Market Access

The company has achieved impressive coverage through agreements with several major health plans and pharmacy benefit managers:

• Express Scripts has added Yesintek to its National Preferred Formulary (NPF) effective March 21, 2025.
• Cigna included Yesintek in its commercial formulary beginning March 21, 2025.
• UnitedHealthcare will add Yesintek to various formularies, including commercial (May 1, 2025), managed Medicaid (March 1, 2025), and Medicare (June 1, 2025).
• CVS Health will include Yesintek from July 1, 2025.
• Optum Rx will add Yesintek to its Premium and Select formularies starting July 1, 2025.

Additionally, Yesintek has been selected for inclusion in formularies of several other healthcare providers, including Navitus, Costco Health Solutions, MedImpact, Priority Health, and the University of Pittsburgh Medical Center (UPMC).

Exclusive Agreements

Notably, Yesintek has been chosen as the exclusive ustekinumab option by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems. This exclusivity highlights the confidence these providers have in Biocon Biologics' product.

Management Commentary

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd, commented on the achievement: "The strong adoption of Yesintek™ by payors in the U.S. reflects their confidence in our science, supply reliability, and commercial capability. The listing of Yesintek™ on multiple formularies is another validation that payors in the U.S. are committed to broaden access to affordable treatment options."

Josh Salsi, Head of North America at Biocon Biologics Inc., added: "More than 100 million Americans — representing 70%-80% of the commercial market — are now covered for Yesintek™ (ustekinumab-kfce) through commercial formularies. This marks a significant step forward in bringing high-quality, affordable biosimilars to patients managing chronic conditions."

About Yesintek

Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. It is available in various formulations, including:

• 45 mg/0.5 mL PFS
• 90 mg/mL PFS
• 45 mg/0.5 mL vial
• 130 mg/26 mL vial

The biosimilar received U.S. Food and Drug Administration (FDA) approval in December 2024.

Market Implications

This widespread market access for Yesintek represents a significant achievement for Biocon Biologics in the competitive US healthcare market. It demonstrates the company's ability to develop high-quality biosimilars and successfully navigate the complex US healthcare system to ensure broad patient access.

The inclusion of Yesintek in multiple formularies, especially as an exclusive option in some cases, positions Biocon Biologics favorably in the growing biosimilars market. This development could potentially lead to increased market share and revenue growth for the company in the coming years.

As the biosimilars market continues to expand, Biocon Biologics' success with Yesintek may set a precedent for its future product launches and market access strategies in the United States and globally.

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has achieved a significant milestone in its European expansion efforts. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of BBL's denosumab biosimilars for bone health indications.

Key Highlights

• The CHMP has recommended approval for two denosumab biosimilar candidates: Vevzuo® and Denosumab BBL (brand name pending approval).
• These biosimilars are designed for distinct therapeutic indications related to bone health.
• The positive opinions are based on comprehensive data packages, including clinical study results.
• The applications were submitted by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics Ltd.

Clinical Evidence

The CHMP's recommendations follow a thorough review of data demonstrating comparability with the reference product. The clinical studies showed equivalent profiles in terms of:

• Pharmacokinetics
• Safety
• Efficacy
• Immunogenicity

Next Steps

The European Commission will now review the CHMP opinions. If approved:

• Detailed information on approved indications and usage will be included in the Summary of Product Characteristics (SmPCs).
• European Public Assessment Reports (EPARs) will be made available in all official European Union languages.

It's important to note that these products are not yet approved for use in the European Union, pending the European Commission's final decision.

Market Implications

This development marks a crucial step for Biocon Biologics in expanding its presence in the European biosimilars market. Denosumab is widely used in the treatment of osteoporosis and other bone-related conditions, representing a significant market opportunity.

Company Statement

A spokesperson for Biocon stated, "These recommendations follow a review of comprehensive data packages, including clinical studies results, which demonstrated comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles."

The positive CHMP opinions for Biocon Biologics' denosumab biosimilars underscore the company's growing capabilities in developing complex biologics and its commitment to expanding access to high-quality, affordable medicines in Europe and globally.