Biocon Limited announced it has secured market entry for its proposed biosimilar, Yesintek™ (Ustekinumab), in several key global markets including Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea, and Kazakhstan. This expansion follows previous agreements for the United States and Europe, offering an affordable treatment option for autoimmune diseases and leveraging the $6.08 billion worldwide sales of the reference brand, Stelara® in 2025.
Biocon Expands Global Reach for Yesintek™ Biosimilar
Biocon Limited has entered into a license agreement with Janssen Sciences Ireland, granting the company the rights to commercialize Yesintek™, its proposed biosimilar to Stelara® (Ustekinumab). This agreement significantly expands the market access for Yesintek™ into a number of additional global territories. Effective immediately, the biosimilar will be available in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea, and Kazakhstan.
Building on Previous Market Entries
This latest milestone builds upon Biocon’s prior announcements regarding market entry dates for Yesintek™ in the United States and key markets in Europe, the UK, Canada, and Japan. The expanded market rights for the biosimilar Ustekinumab are poised to provide patients in these regions with a more affordable and effective treatment option for various autoimmune diseases.
Therapeutic Significance and Market Potential
Yesintek™ is identified as a human interleukin-12 and -23 antagonist that targets IL-12 and IL-23 mediated signalling in immune-mediated diseases. It has already received approval for treating conditions such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The reference brand, Stelara®, recorded substantial worldwide sales of $6.08 billion in 2025, indicating a significant market opportunity for Biocon’s biosimilar offering.
Regulatory Approvals and Future Outlook
The company noted that product launches in all these newly acquired countries and regions are contingent upon obtaining the necessary regulatory approvals. Biocon’s strategic expansion into these diverse markets underscores its commitment to making advanced biologic therapies more accessible globally.
Source: BSE
