Biocon Biologics Secures Market Entry for Bmab 1200, a Proposed Biosimilar to Stelara®, in Europe, UK, Canada, and Japan

Biocon Biologics Ltd (BBL) has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, resolving patent disputes and securing market entry for its proposed biosimilar, Bmab 1200, in Europe, the UK, Canada, and Japan. Regulatory filings in these markets are under review. BBL earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025. The U.S. FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Bmab 1200, a biosimilar to Stelara® (Ustekinumab), is expected to strengthen BBL's immunology franchise, offering an affordable and effective treatment option for patients impacted by autoimmune diseases. Stelara® had worldwide sales of $10.85 billion in 2023.