Biocon Biologics finalises agreement for Bmab 1200 market entry in Europe, UK, Canada, and Japan

Biocon Biologics (BBL), a biosimilars company and subsidiary of Biocon announced today that it has signed a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) for the global commercialisation of its biosimilar product Bmab 1200.

Under the terms of the agreement, Biocon Biologics has resolved patent disputes with Janssen, securing market entry dates for Bmab 1200 in Europe, the UK, Canada, and Japan. Regulatory filings in these markets are currently under review.

Earlier, Biocon Biologics announced a similar settlement agreement in the United States, securing a Bmab 1200 launch no later than February 22, 2025, pending U.S. FDA approval. The U.S. FDA has accepted the Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd, stated, “This settlement agreement is 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.”

Stelara (Ustekinumab) is a monoclonal antibody medication approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The reference brand, Stelara, had worldwide sales of $10.85 billion in 2023 (1).

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(1): Johnson & Johnson Reported 2023 Sales All trademarks, registered or unregistered, are the property of their respective owners. Product launches in all the countries/ regions are subject to regulatory approval.