Biocon Biologics Secures Strong Market Access for Yesintek in the U.S.

Biocon Biologics Ltd. (BBL), a Biocon Ltd. subsidiary, has now launched YESINTEK™ (ustekinumab-kfce) in the United States, achieving a milestone in the market for biosimilars. The medicine, a biosimilar of Stelara® (ustekinumab), is indicated for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. A detailed snapshot follows:

 

Key Highlights

 

Launch & Market Entry:

 

YESINTEK was launched on February 24, 2025, and Biocon became one of the earliest companies to launch a biosimilar option for Stelara® in the United States.

 

The product comes in various formulations such as 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

 

CEO's Comment on Expansion:

 

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, underscored that the launch reflects Biocon's dedication to increasing access to high-quality biosimilars.

 

He said, "The launch of YESINTEK is an important milestone in our mission to enhance the lives of patients with inflammatory diseases."

 

Patient Assistance & Insurance Coverage:

 

YESINTEK will be covered by commercial payors at launch, providing affordable access to eligible patients.

 

The copay program enables eligible patients to pay as low as $0, helping make treatment more affordable.

 

Clinical Studies & FDA Approval:

 

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

 

Clinical studies have established that YESINTEK shares the same pharmacokinetic, safety, efficacy, and immunogenicity profile with Stelara®.

 

Impact on Biocon's Market Position:

 

Biocon Biologics' first biosimilar launch in the U.S. enhances its presence in the global immunology space.

 

Biocon stocks have appreciated 42% in the past two years, symbolizing investor belief in its strategy of biosimilars.

 

Future Outlook & Expansion Plans:

 

Biocon Biologics plans to increase its biosimilars portfolio through future launches across oncology and ophthalmology.

 

The organization is presently diligently pursuing new approvals for biosimilars such as Yesafili™, an interchangeable biosimilar to Eylea®.

 

This launch reiterates Biocon Biologics' focus on healthcare affordability, making cost-effective medicines available to treat patients suffering from chronic autoimmune conditions.

 

Sources: Biocon Biologics, Economic Times, Biocon Press Releases