Biocon Licenses Yesintek Biosimilar to Janssen for Australia, Brazil and China

Biocon Limited has signed a license agreement with Janssen Sciences Ireland to commercialize Yesintek, its proposed biosimilar to Stelara (Ustekinumab), in nine additional markets, ScanX reported on October 26, 2026. The agreement grants immediate market entry rights in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan.

What the Janssen License Covers

The license covers commercialization of Yesintek, a human interleukin-12 and interleukin-23 antagonist designed to disrupt IL-12 and IL-23 mediated signalling in immune-mediated diseases. Yesintek has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

The reference brand, Stelara, recorded worldwide sales of $6.08 billion in 2025. The agreement builds on previously announced deals that secured market entry dates for Yesintek in the United States, Europe, the UK, Canada and Japan.

Biocon said product launches in all listed countries and regions remain subject to regulatory approval. The license agreement clears the way for commercialization activities, allowing Biocon to proceed with necessary local regulatory processes to bring the product to these markets.

Biocon's Biosimilar Portfolio at a Glance

According to akta.pro company records, Biocon and Biocon Biologics operate across more than 120 countries with a biosimilars and generics portfolio, and Biocon is the third-largest insulin supplier globally by volume. The company has announced a strategy to become the world's top insulin supplier within five years by doubling manufacturing capacity and targeting Asia, Africa, Latin America, Canada, the Middle East and Southeast Asia.

Earlier Biocon Licensing and Approval Steps

On October 14, 2026, Biocon entered a global settlement and license agreement with Genentech, securing earliest launch dates for Pebrilzo, its biosimilar to Perjeta, resolving pending patent disputes in the U.S., Canada and other jurisdictions, with EU and UK launches in the first quarter of calendar year 2027 and a U.S. launch in the third quarter of calendar year 2028, ScanX reported.

On September 21, 2026, Biocon's pertuzumab biosimilar Pebrilzo received a positive CHMP opinion recommending EU marketing authorization, according to AInvest. On September 7, 2026, Biocon, Bahiafarma and Bionovis secured a 10-year Brazil PDP deal for Pertuzumab, granting exclusive access to the public healthcare market covering about 70% of demand, The Times of India reported.

Regulatory Approvals Ahead for Yesintek

Biocon said launches in the nine markets remain subject to regulatory approval in each country.