Biocon Biologics secures deal with Janssen to launch biosimilar Bmab 1200

Agreement clears way for Indian company to launch treatment in Europe, Canada and other markets

India's Biocon Biologics said on Thursday it has signed a settlement and licence agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen).

The deal clears the way for commercialising Biocon's Bmab 1200, a proposed biosimilar that competes with Janssen's Stelara, in Europe, the United Kingdom, Canada, and Japan. Biosimilar, according to one definition, is similar to another biological medicine that has already been approved, called the reference medicine. Stelara has been approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Under the terms of a settlement agreement, Bengaluru-headquartered Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in the markets listed above. Regulatory filings in these markets are currently under review, Biocon Biologics said.

“This settlement agreement is a 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,” said Shreehas Tambe, chief executive officer and managing director of Biocon Biologics.

Biocon Biologics, in February, announced a settlement agreement in the United States for Bmab 1200 and it is expected to launch the treatment in February 2025 after getting approval from the US Food and Drug Administration.

Stelara (Ustekinumab) is a monoclonal antibody medication that prevents the abnormal regulation of interleukin IL-12/23-associated immune diseases. The reference brand, Stelara, had worldwide sales of $10.85 billion in 2023.