Biocon Biologics Settles with Janssen to Launch Biosimilar Bmab 1200 Across Key Markets

The agreement resolves patent disputes and sets market entry dates for Bmab 1200 in these regions, according to a stock exchange filing by Biocon.

Biocon Biologics has signed a settlement agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, collectively known as Janssen, to commercialize its biosimilar Bmab 1200, a counterpart to Stelara (Ustekinumab), in Europe, the United Kingdom, Canada, and Japan.

The agreement resolves patent disputes and sets market entry dates for Bmab 1200 in these regions, according to a stock exchange filing by Biocon.

"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," Shreehas Tambe, CEO & Managing Director of Biocon Biologics, said.

Stelara (Ustekinumab), the reference drug, is a monoclonal antibody targeting interleukin IL-12/23, used to treat autoimmune conditions such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The drug generated $10.85 billion in global sales in 2023, as reported by Johnson & Johnson.

Previously, Biocon Biologics had settled with Janssen in the United States, paving the way for a Bmab 1200 launch by February 22, 2025, pending approval from the US Food and Drug Administration (FDA).

The FDA has accepted the Biologics License Application (BLA) for Bmab 1200 under the 351(k) pathway for biosimilars.

In related financial news, Biocon reported a 550.59% year-on-year increase in net profit to INR 659.7 Cr for the first quarter ending June 30, 2024, compared to INR 101.4 Cr in the same period last year. Revenue from operations rose marginally by 0.3% to INR 3,432.9 Cr.

Biocon Limited is an Indian biopharmaceutical company based in Bengaluru. Founded by Kiran Mazumdar Shaw in 1978, the company aims to be an innovation-led global biopharmaceutical enterprise.

Biocon claims to offer a commercial presence in around 120 countries, with direct operations in the United States, Canada, Europe, and nine key emerging markets. These include India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines.