India Pharma Outlook Team | Monday, 26 October 2026
Biocon has secured rights to commercialize Yesintek, its biosimilar to Johnson & Johnson’s Stelara, in nine additional high-growth markets through a settlement with Janssen Sciences Ireland.
The agreement gives the company immediate market-entry rights in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan, subject to local regulatory clearances.
This latest deal builds on earlier settlements that already cover the United States, Europe, the UK, Canada and Japan.
Together, the agreements strengthen Biocon’s global ustekinumab franchise and open high-growth markets that can drive long-term growth.
The nine new high-growth markets expand Biocon’s reach across Asia, Latin America and Oceania. Stelara generated USD 6.08 billion in worldwide sales in 2025, highlighting the scale of the opportunity even as biosimilar competition intensifies.
The settlement removes patent barriers and grants commercialization rights with immediate effect. However, product launches in each territory still depend on local regulatory approvals. The agreement does not equal automatic market entry.
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China, Brazil and South Korea stand out as high-growth markets for immunology drugs. In several of these countries, originator prices remain high relative to local income levels, creating stronger demand for more affordable biosimilars.
Biocon can now position Yesintek as an accessible treatment option for patients with autoimmune conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The deal fits Biocon’s methodical, settlement-driven strategy. Instead of pursuing isolated market entries, the company systematically assembles near-global rights for Yesintek. This approach builds a coherent international franchise and improves the product’s long-term commercial potential across both developed and emerging markets.
Yesintek strengthens Biocon’s immunology portfolio and reduces reliance on its traditional diabetes and oncology segments. Multiple companies target Stelara biosimilars, so early settlement positions can deliver timing advantages in key countries.
Supplying nine additional complex markets will test manufacturing scale, regulatory execution and supply chain reliability. Successful launches will depend on Biocon’s ability to meet local requirements and ensure consistent product availability.
The latest agreement expands Biocon’s geographic reach into high-growth markets and advances its biosimilar ambitions. The real test lies in converting these market-entry rights into successful regulatory approvals and commercial launches across the new territories.