Biocon Biologics Secures Market Entry for Bmab 1200 in Europe, UK, Canada, and Japan

Bengaluru, India – August 29, 2024
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Limited, announced it has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen). This agreement paves the way for the commercialization of its Bmab 1200, a proposed biosimilar to Stelara® (Ustekinumab), in Europe, the United Kingdom (UK), Canada, and Japan.

Key Aspects of the Settlement

Under the terms of the settlement, Biocon Biologics has resolved patent disputes with Janssen, allowing market entry for Bmab 1200 in key global markets.

Regulatory filings in these markets are currently under review, ensuring compliance and adherence to international standards.

Previous Developments in the U.S. Market

Biocon Biologics had earlier announced a settlement agreement for launching Bmab 1200 in the United States no later than February 22, 2025, pending approval by the U.S. FDA. The U.S. FDA has already accepted the Company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) under the 351(k) pathway.

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CEO Statement

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd, stated:
“This settlement agreement reflects our proven track record in science and innovation and marks a significant milestone in our mission to bring Bmab 1200 (bUstekinumab) to global markets. This addition will significantly enhance our immunology portfolio, providing affordable and effective treatment options for patients affected by autoimmune diseases."

About Stelara® (Ustekinumab)

Stelara® is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23-associated immune diseases. It is approved for treating several conditions, including psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The reference brand Stelara® had worldwide sales of $10.85 billion in 2023.

About Biocon Biologics Limited

Biocon Biologics Ltd. (BBL) is a unique, fully integrated, global biosimilars company focused on transforming healthcare and improving lives. The company leverages its ‘lab to market’ capabilities to provide affordable access to high-quality biosimilars to millions of patients across 120+ countries. With a pipeline of 12 biosimilar assets in development, Biocon Biologics is advancing healthcare through cutting-edge science, innovative tech platforms, and global-scale manufacturing capabilities.

The company has commercialized eight biosimilars in key emerging and advanced markets, including the U.S., Europe, Australia, Canada, and Japan. As part of its Environmental, Social, and Governance (ESG) commitment, Biocon Biologics is dedicated to achieving the UN Sustainable Development Goals (SDGs).

Forward-Looking Statements
This press release may contain forward-looking statements based on current expectations and beliefs concerning future developments. These involve risks and uncertainties that could cause actual results to differ materially. Biocon does not undertake any obligation to update forward-looking statements contained in this release.

Conclusion
Biocon Biologics' settlement agreement and market entry for Bmab 1200 in Europe, the UK, Canada, and Japan reinforce its leadership in the global biosimilars market. The company remains focused on offering affordable treatments and expanding its presence across key international markets.

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