Biocon Biologics, a subsidiary of Biocon Ltd., has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Ustekinumab biosimilar. This biosimilar is a version of Johnson & Johnson’s Stelara® and will be marketed in Japan by Biocon’s partner, Yoshindo Inc. Ustekinumab is a monoclonal antibody used to treat plaque psoriasis and psoriatic arthritis. This approval marks another milestone for Biocon Biologics, expanding its global reach in the biosimilars market. The company previously entered into a settlement and licensing agreement with Janssen Biotech, Inc. in August 2024, resolving patent litigation related to Stelara®. This agreement allows Biocon Biologics to commercialize its Ustekinumab biosimilar in the US no later than February 22, 2025.
Key Insights:
- Expanding Market Access: This approval grants Biocon Biologics access to the Japanese pharmaceutical market, known for its high standards and significant potential.
- Strengthened Portfolio: The addition of another approved biosimilar reinforces Biocon Biologics’ position as a key player in the global biosimilars industry.
- Potential for Revenue Growth: The approval opens up new revenue streams for Biocon Biologics, contributing to the company’s overall financial performance.
- Increased Competition: The availability of Biocon’s biosimilar may intensify competition in the Japanese market for treatments for plaque psoriasis and psoriatic arthritis.
Investment Implications:
- Positive Sentiment: The news is likely to boost investor confidence in Biocon Biologics and its parent company, Biocon Ltd.
- Potential for Stock Price Appreciation: The increased revenue potential and market expansion may positively influence Biocon’s stock price.
- Long-term Growth Prospects: This approval aligns with Biocon Biologics’ strategy of expanding its global presence and product portfolio, contributing to its long-term growth prospects.
- Monitor Market Response: Investors should monitor the market response to Biocon’s Ustekinumab biosimilar in Japan, including its uptake and impact on competitors.
Sources:
- Biocon’s Official Announcement: https://nsearchives.nseindia.com/corporate/BioconLtd_07012025081522_SIGNEDIntimation07012025.pdf
- Previous News on Settlement with Janssen: https://www.biocon.com/emas-chmp-recommends-approval-of-biocon-biologics-yesintek-biosimilar-to-jjs-stelara/
