Signs a settlement and license agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson

Biocon Biologics has signed a settlement and license agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the UK, Canada, and Japan.

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

Biocon Biologics earlier announced a settlement agreement in the US for a Bmab 1200 launch no later than February 22, 2025, once approved by the US FDA. The US FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

Shreehas Tambe, CEO and MD, Biocon Biologics, said, "The 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."