Biocon Biologics and Yoshindo Expand Japan Access to Ustekinumab Biosimilar Following Regulatory Approval

Unknown Apr 02, 2026 2 Views

Biocon Biologics Ltd, a part of Biocon Ltd, has made a significant milestone in its global biosimilars strategy by expanding access to its Ustekinumab biosimilar in Japan through an exclusive partnership with Yoshindo Inc. This action comes after the Japanese health regulator cleared Biocon's Ustekinumab BS subcutaneous injection, a biosimilar to Johnson & Johnson's Stelara®, for the indication of psoriasis vulgaris and psoriatic arthritis. The alliance is intended to bring high-quality, affordable biologic medicines within reach of more Japanese patients with chronic autoimmune diseases.

Key Highlights

Regulatory Approval in Japan

The Japan PMDA approved Biocon Biologics' Ustekinumab BS subcutaneous injection in January 2025, a major milestone for the company's global biosimilar pipeline.

Strategic Partnership with Yoshindo:

Yoshindo Inc. has exclusive rights to market Ustekinumab and Denosumab biosimilars in Japan through a strategic out-licensing arrangement. The transaction is for an addressable market opportunity of around $700 million and entails upfront and milestone payments to Biocon Biologics.

Increased Patient Access:

With Yoshindo as its sole commercial partner, Biocon Biologics will use Yoshindo's entrenched presence in Japan's pharmaceutical market to increase access to cost-effective therapies for psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Biocon Biologics currently boasts a developing pipeline of 20 biosimilar products, the most recent of which, Ustekinumab, has gained regulatory approval in a developed economy. Biocon was the first Indian company to launch a biosimilar in Japan after successfully launching Insulin Glargine in 2016.

Market Impact and Future Outlook:

The upcoming February 2025 launch of Ustekinumab in Japan is likely to drive Biocon's growth in developed and emerging economies. The approval also reaffirms Biocon's leadership as a global biosimilar company and its mission for accessible healthcare innovations.

Insight

Biocon Biologics' approval and wider commercialization of the Ustekinumab biosimilar in Japan, under collaboration with Yoshindo, marks a significant milestone in the international growth strategy of the company. Through filling immunology and bone health unmet needs, Biocon is set to make a lasting difference in patient access and affordability in one of the world's leading healthcare markets.

Source:

[TradingView/Reuters]

[Economic Times]

[CNBC-TV18]

[Biocon.com]

[Business Upturn]

[Biocon.com Press Release]

[Business Standard]

[IPO Central]

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