NEW DELHI: Biocon Biologics on Thursday said it has signed a deal with Janssen to launch a biosimilar for the treatment of autoimmune diseases in Europe, the UK, Canada and Japan.
The Biocon subsidiary has entered into settlement and license agreements with Janssen Biotech Ltd, Janssen Sciences Ireland Ltd and Johnson & Johnson Co. The agreement paves the way for commercialisation of Bmab 1200, a proposed biosimilar to Stelara.
Biocon Biologics said in a statement that, in accordance with the terms of the settlement agreement, it has resolved the patent dispute with Janssen and secured market entry dates in Europe, the UK, Canada and Japan.
The company added that regulatory filings in those markets are currently under review.
Biocon Biologics had earlier announced a settlement agreement in the US to launch Bmab 1200 by February 22, 2025, once approval from the US Food and Drug Administration (USFDA) is obtained.
U.S. health authorities have accepted for review the company's Biologics License Application (BLA) for Bmab 1200.
“This settlement agreement is a testament to our track record of science and innovation and marks another important milestone in our efforts to bring biosimilar Bmab 1200 (bUstekinumab) to the global market,” said Shreehas Tambe, CEO and Managing Director, Biocon Biologics.
He further added that Bmab 1200 will significantly strengthen the company's immunology franchise, enabling it to provide affordable and effective treatment options to patients suffering from autoimmune diseases.
Stelara (ustekinumab) is approved to treat psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Stelara achieved global sales of US$10.85 billion in 2023.
Biocon shares were trading up 0.9 per cent at Rs 360.10 per share on the BSE.
Published on August 29, 2024 at 06:10 IST
