Biocon Ltd’s Subsidiary Secures Approval for Bmab 1200 in Europe, UK, Canada, and Japan

On August 29, 2024, Biocon Ltd informed the stock exchanges that the company’s subsidiary Biocon Biologics Ltd (BBL) had signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen).

This agreement allows Biocon Biologics to proceed with the commercialisation of Bmab 1200, a proposed biosimilar to Stelara®, across Europe, the United Kingdom (UK), Canada, and Japan. The settlement resolves ongoing patent disputes and secures market entry dates in these regions, with regulatory filings currently under review.

Earlier this year, Biocon Biologics had also secured a settlement in the United States, permitting the launch of Bmab 1200 no later than February 22, 2025, pending approval from the U.S. FDA. The FDA has accepted Biocon’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway, a crucial step toward market approval.

Stelara® (Ustekinumab), the reference product, is a monoclonal antibody medication used to treat various immune-related conditions, including psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The medication had worldwide sales of $10.85 billion in 2023, highlighting its significant market presence and the potential for Bmab 1200 to capture a share of this lucrative market.

The successful settlement with Janssen positions Biocon Biologics to expand its global footprint and offer a competitive biosimilar option in major markets, aligning with its strategy to enhance access to critical biologic therapies.

Commenting on this development, the CEO and Managing Director of Biocon Biologics Ltd, Shreehas Tambe, said, “This settlement agreement is a testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases.”

On August 29, 2024, the share price of Biocon Ltd opened at ₹364.00, touching the day’s high at ₹364.95, as of 9:44 AM on the NSE.

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