Biocon’s arm to commercialize Bmab 1200 in global markets

29 Aug 2024 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the United Kingdom (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. 

Earlier, Biocon Biologics announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the USFDA. The USFDA has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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