Biocon Biologics, a subsidiary of Biocon Ltd, has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, collectively known as Janssen. This agreement allows Biocon Biologics to proceed with the commercialisation of its proposed biosimilar, Bmab 1200, which is designed to compete with Stelara, in Europe, the UK, Canada, and Japan, the company informed in a stock exchange filing. The settlement resolves existing patent disputes and secures market entry dates in these regions. Regulatory filings for Bmab 1200 are currently under review.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd, remarked, "This settlement agreement highlights our strong track record in science and innovation and marks a significant milestone in our efforts to introduce Bmab 1200 (bUstekinumab) to global markets. Bmab 1200 will greatly enhance our immunology portfolio, providing an affordable and effective treatment option for patients with autoimmune diseases."
Stelara (Ustekinumab) is a monoclonal antibody used to regulate interleukin IL-12/23, targeting immune diseases. It is approved for treating psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Stelara achieved global sales of $10.85 billion in 2023, the press statement said.
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