Biocon Expands Yesintek Commercialisation to Nine Markets

The short version

• Biocon has secured commercialisation rights for Yesintek in nine additional international markets.
• The agreement with Janssen Sciences Ireland covers markets including Australia, Brazil and China.
• Commercial launches depend on regulatory approvals, while Stelara recorded global sales of $6.08 billion in 2025.

Biocon Limited has signed a licensing agreement with Janssen Sciences Ireland to commercialise Yesintek, its proposed biosimilar to Stelara, in nine additional international markets. The agreement expands Biocon's reach across Asia, Latin America and other regions where patients are treated for chronic immune mediated diseases.

The newly covered markets are Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan. The agreement is effective immediately, although commercial launches in these territories will depend on the required regulatory approvals.

Yesintek is being developed as a biosimilar to Stelara, whose active ingredient is ustekinumab. The reference medicine generated $6.08 billion in worldwide sales in 2025, indicating the scale of the existing market for this treatment. Biocon's latest agreement adds more potential markets to its existing commercialisation arrangements.

Which countries are covered by the agreement?

The licensing agreement extends Biocon's commercialisation rights to nine markets. These include established pharmaceutical markets such as Australia and South Korea, alongside major markets such as China and Brazil. Hong Kong, Israel, Kazakhstan, Mexico and New Zealand are also covered.

Market	Region
Australia	Asia Pacific
Brazil	Latin America
China	Asia
Hong Kong	Asia
Israel	Middle East
Mexico	North America
New Zealand	Asia Pacific
South Korea	Asia
Kazakhstan	Central Asia

The agreement adds to earlier arrangements between Biocon and Janssen that covered the United States, Europe, the United Kingdom, Canada and Japan. These earlier agreements had established a presence for Yesintek across several major pharmaceutical markets. The latest deal broadens that geographical reach, although actual sales in each newly covered territory will depend on local regulatory decisions.

For Biocon, the distinction between signing a licensing agreement and starting commercial sales is important. The agreement establishes the commercialisation arrangement for the additional markets, but it does not confirm that the product is already available to patients in all nine territories.

What is Yesintek and how does it work?

Yesintek is a proposed biosimilar to Stelara, a medicine containing ustekinumab. It is described as a human interleukin 12 and interleukin 23 antagonist. These proteins are involved in immune system signalling, and the medicine interferes with pathways mediated by interleukin 12 and interleukin 23.

The treatment is associated with several chronic inflammatory conditions. The supplied product information identifies four indications: Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Particulars	Details
Product	Yesintek
Reference medicine	Stelara
Active ingredient	Ustekinumab
Drug class	Interleukin 12 and interleukin 23 antagonist
Indications listed	Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
Latest licensing agreement	Janssen Sciences Ireland
Newly covered markets	Nine
Reference medicine sales in 2025	$6.08 billion

Biosimilars are biological medicines developed to be highly similar to an existing reference biological medicine. They are assessed under applicable regulatory requirements before they can be marketed. Their commercial role can include introducing another treatment option in a market where the reference medicine is already established.

However, the availability of a biosimilar does not automatically mean that treatment costs will fall by a specific amount. Pricing depends on factors such as regulatory status, competition, reimbursement arrangements and market access. The licensing announcement does not specify Yesintek's expected launch prices or the discounts it might provide against Stelara.

Why does Stelara's sales figure matter?

Stelara's worldwide sales of $6.08 billion in 2025 provide an indication of the commercial scale of the reference medicine. Treatments for chronic immune mediated diseases can involve long term care, creating demand for medicines that manage these conditions over extended periods.

For Biocon, access to additional territories increases the number of markets in which it can seek to commercialise Yesintek under the licensing arrangements. The commercial outcome will depend on how quickly approvals are obtained and when launches begin.

The reference medicine's sales figure should not be treated as an estimate of revenue available to Biocon. Stelara's worldwide sales cover the existing reference product market, while Yesintek would need to compete for prescriptions in individual countries. Market share, pricing, reimbursement and the timing of launches will affect the revenue that Biocon could generate.

The agreement also does not disclose financial terms such as upfront payments, royalties, minimum sales commitments or expected revenue from the nine territories. Without those details, the direct financial contribution of the new licensing arrangement cannot be quantified.

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Biocon's earlier market access agreements

The latest agreement follows licensing arrangements that covered the United States, Europe, the United Kingdom, Canada and Japan. Together, these agreements give Biocon commercialisation rights across a broader collection of markets, subject to the terms of the relevant arrangements and local regulatory requirements.

Expanding geographical coverage can help a biosimilar developer pursue sales across different healthcare systems. However, each market has its own approval process and commercial conditions. A product's regulatory status in one country does not establish that it can be launched in another.

For Yesintek, the next stage involves securing the necessary approvals in the newly covered territories. Biocon will also need to establish commercial availability in those markets before the licensing agreement can translate into sales.

The announcement does not provide a country by country launch schedule, an expected date for the first commercial sale or revenue guidance for Yesintek. It also does not quantify the investment required to enter the nine markets.

What investors should watch

Biocon's latest licensing agreement expands the potential commercial reach of Yesintek, but the eventual financial contribution remains uncertain. Several developments will help clarify the business impact.

• Regulatory approvals in Australia, Brazil, China and the other covered markets.
• Announcements confirming the first commercial launches and product availability.
• Details of pricing, reimbursement and competition with Stelara in individual territories.
• Any disclosure of licensing payments, royalties or expected sales from Yesintek.

The distinction between rights secured and revenue earned will remain important when assessing the agreement. Regulatory clearance and actual product launches will determine when the expanded market access can begin to contribute to Biocon's business.

About Biocon

Biocon Limited is an Indian biopharmaceutical company. In this announcement, the company's focus is on expanding the commercial reach of Yesintek, its proposed biosimilar to Stelara, through licensing arrangements with Janssen Sciences Ireland.

The latest agreement covers nine additional international markets. Its immediate effect is to extend the territories covered by the commercialisation arrangement, while sales in those markets remain subject to regulatory approvals. Future disclosures on approvals, launch dates and commercial terms will provide more information about the financial contribution of Yesintek.

Frequently asked questions

What is Biocon's latest agreement about?

Biocon has signed a licensing agreement with Janssen Sciences Ireland to commercialise Yesintek in nine additional markets. The product is a proposed biosimilar to Stelara, and launches in the covered territories depend on regulatory approvals.

Which nine countries and territories are covered by the Yesintek agreement?

The agreement covers Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan. It extends commercialisation rights beyond the markets covered by earlier arrangements.

What is Yesintek used to treat?

Yesintek is described as a biosimilar to ustekinumab, the active ingredient in Stelara. The listed indications are Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, subject to applicable approvals.

How much did Stelara generate in global sales in 2025?

Stelara recorded worldwide sales of $6.08 billion in 2025. This figure relates to the reference medicine and does not represent Biocon's revenue from Yesintek.

When will Yesintek launch in the nine additional markets?

The agreement is effective immediately, but commercial launches require the relevant regulatory approvals. No country specific launch dates have been provided in the announcement.

Will the agreement immediately increase Biocon's revenue?

The agreement does not establish an immediate increase in revenue. Financial benefits will depend on regulatory clearances, commercial launches, pricing and demand in the covered markets.