#United States #Biocon Biologics #YESINTEK™ #Stelara® #Bridgewater, N.J.

Biocon Biologics Launches YESINTEK™ in the United States

In an exciting advancement for the healthcare sector, Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., has officially launched YESINTEK™ (ustekinumab-kfce) in the United States. Announced on February 24, 2025, this launch makes YESINTEK one of the early entrants in the biosimilar market for Stelara® (ustekinumab), which is used to treat several chronic autoimmune diseases including Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Increasing Patient Accessibility

Through the introduction of YESINTEK, Biocon Biologics aims to enhance access to effective treatment regimens for patients suffering from these common inflammatory conditions. YESINTEK will be available in a variety of formulations, mirroring those of the original Stelara. Specifically, the product will come in:

• - 45 mg/0.5 mL pre-filled syringe (PFS)
• - 90 mg/mL PFS
• - 45 mg/0.5 mL vial
• - 130 mg/26 mL vial

These options not only ensure that patients can receive treatment that suits their needs but also provide a cost-effective alternative, potentially easing the financial burden on individuals with chronic health issues.

Commitment to Quality and Patient Care

According to Shreehas Tambe, CEO and Managing Director of Biocon Biologics, the launch is a reflection of the company’s ongoing commitment to improving the lives of patients facing inflammatory conditions. This product represents a significant milestone as it is the first biosimilar to be introduced in the United States since Biocon Biologics transitioned into a fully integrated global entity in the biosimilars sector.

Laura Wingate, Chief Education, Support & Advocacy Officer of the Crohn’s & Colitis Foundation, emphasized the importance of YESINTEK, noting that the burden of these diseases significantly impacts patients' daily lives. With the introduction of YESINTEK, patients are presented with more viable treatment options, an essential development for those living with these chronic conditions.

Robust Support Programs

Upon its launch, YESINTEK will feature comprehensive commercial payor coverage, enhancing its availability. Additionally, Biocon Biologics is rolling out a solid patient assistance program that includes services such as benefits verification and copay support, allowing eligible patients to potentially access the medication for as little as $0. This level of support signifies Biocon's dedication to ensuring that financial constraints do not hinder access to critical healthcare solutions.

The Science Behind YESINTEK

YESINTEK functions as a monoclonal antibody that inhibits IL-12 and IL-23 mediated signaling pathways associated with immune-mediated diseases. In clinical studies, the biosimilar demonstrated significant comparability to Stelara regarding pharmacokinetic, safety, efficacy, and immunogenicity profiles. The rigorous evaluation led to its approval from the U.S. Food and Drug Administration (FDA) in December 2024, substantiating its profile as a reliable therapeutic agent.

Healthcare Provider Insights

For healthcare professionals, YESINTEK offers versatility in treatment, as it covers the same indications and dosing options as Stelara. This consistency ensures that patients can transition to YESINTEK without complication, thereby continuing their treatment in a seamless manner. Josh Salsi, Head of North America for Biocon Biologics Inc., reiterated confidence in the product's quality, deriving from Biocon’s strong background in the biosimilars field.

As a part of its mission, Biocon Biologics is dedicated to delivering high-quality biosimilars across more than 120 countries, increasing the accessibility of critical therapies and ultimately working towards better healthcare outcomes. With a robust pipeline of future biosimilar products in development, Biocon is poised to continue its leadership in the global biosimilar landscape. For more information about YESINTEK, patients and healthcare providers can visit www.yesintek.com and www.yesintekHCP.com, respectively.