#United States #Biocon #Bridgewater #YESINTEK™ #Ustekinumab

Biocon Biologics Achieves Major Market Access Expansion for Yesintek™

Biocon Biologics Ltd. (BBL), a leading global biosimilars company under Biocon Ltd, has achieved a significant milestone by securing market access agreements for its biosimilar product, Yesintek™ (ustekinumab-kfce). This development opens doors for over 100 million lives across the United States, marking a crucial step in the company’s mission to provide affordable healthcare options.

The newly formed agreements, which include several key health plans, illustrate a strong commitment to increase availability and accessibility to this vital treatment. Notably, major players such as Express Scripts have welcomed Yesintek to their National Preferred Formulary effective March 21, 2025, while Cigna has included Yesintek in its commercial formulary starting on the same date. UnitedHealthcare has also adopted Yesintek across multiple formularies from May 1, 2025, for commercial patients, and from March and June 2025, for managed Medicaid and Medicare respectively. CVS Health and Optum Rx are set to add Yesintek to their formularies by July 2025.

These agreements not only contribute to the broader acceptance of Yesintek but also demonstrate the growing recognition of its reliability and efficacy as a biosimilar to Stelara® (ustekinumab). According to Josh Salsi, Head of North America for Biocon Biologics Inc., this coverage translates to approximately 70%-80% of the commercial market in the U.S., signaling a robust trend toward the adoption of quality biosimilars, particularly for patients managing chronic conditions like Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis.

The introduction of Yesintek is a pivotal achievement for Biocon Biologics, marking its first product launch in the U.S. as a fully integrated biosimilars enterprise. Shreehas Tambe, CEO and Managing Director of Biocon Biologics, emphasized that the strong uptake by payors reflects not only trust in their scientific advancements and stable supply chains but also denotes an essential shift towards making advanced treatment options more accessible and affordable for patients.

Yesintek is specifically designed as a monoclonal antibody to inhibit IL-12 and IL-23 signaling pathways associated with immune-mediated conditions. The product is available in the same formulations as Stelara®, allowing healthcare providers to offer a seamless transition for patients currently using Stelara. With formulations including 45 mg/0.5 mL prefilled syringes and vials of various sizes, Yesintek offers versatile options to healthcare professionals.

The product's FDA approval, received in December 2024, follows extensive analysis ensuring that Yesintek is highly comparable to Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity. The clinical foundation supporting its efficacy included results from Phase 3 STELLAR-2 studies which uncovered no meaningful differences compared to the reference product.

As patients across the U.S. gear towards more cost-effective treatment solutions, Yesintek emerges as a beacon of hope within the crowded pharmaceuticals landscape, promising a future where high-quality biosimilars will play a crucial role in healthcare solutions. Biocon’s strategic efforts to increase the access to such innovative therapies underscore their commitment to improving patient outcomes and addressing long-standing healthcare challenges effectively. Through innovative approaches and a focus on quality, Biocon Biologics is setting a standard in the biosimilars market, reshaping perceptions around biologic treatments, and paving the way for future advancements.

As the company continues to finalize additional agreements with more health carriers, the outlook for Yesintek remains positive. With a strong foundation of clinical data, regulatory backing, and an expanding formulary presence, Biocon Biologics is well-positioned to transform the biosimilars landscape in the U.S. and beyond.