Biocon secures market entry for Bmab 1200, a Stelara biosimilar

Indian drugmaker Biocon Ltd’s (BSE: 532523) biosimilars subsidiary Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson (NYSE: JNJ) subsidiaries (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), 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 USA for a Bmab 1200 launch no later than February 22, 2025, once approved by the US Food and Drug Administration (FDA). The FDA has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.