Ustekinumab

Approved as a biosimilar to Stelara®, bUstekinumab (Yesintek™) marks Biocon Biologics’ expansion into the immunology therapeutic area. The development program was initiated in 2018 and unfolded during peak of the COVID-19 pandemic, one of the most challenging periods for global healthcare and scientific innovation. Despite widespread lockdowns, limited lab access, and supply chain constraints, our teams sustained progress through agile operations, hybrid workflows, and cross- functional collaboration, demonstrating remarkable resilience and scientific agility.

What makes this achievement significant is the speed and scale at which the development was executed. bUstekinumab is one of the first programs in our portfolio, with four distinct product presentations, which were developed in parallel. Building on our legacy, expertise, and scientific depth in biosimilar development, Yesintek™ stands out as our fastest lab-to-market success story. The product received approvals in the EU and U.S in December 2024, followed by Japan in January 2025, making it our second biosimilar to be approved across all three ICH regions, and the first to achieve this milestone within a single fiscal year.

This reflects the confidence in the quality, efficacy, and safety of the product and reaffirms Biocon Biologics’ ability to deliver science-driven, globally competitive biosimilars. These approvals further underscore our commitment to expanding access to high-quality biosimilars in the immunology space.

The commercial launch of Yesintek® in the U.S., Germany, and Japan stands as a testament to seamless cross-functional collaboration, spanning R&D, MSAT, Manufacturing, Supply Chain, and Regulatory teams, culminating in a true lab-to- market success story.