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Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, Japan
![Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, Japan Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, Japan](https://medicaldialogues.in/h-upload/2024/02/09/750x450_231921-biocon-50.webp)
Bangalore: Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, announced today that the Company 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.
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the U.S. FDA. The U.S. FDA has accepted the Company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
Read Also: Biocon gets USFDA nod for antifungal medication Micafungin
Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “This settlement agreement is 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.
Read also: Biocon Biologics plans to raise Rs 4,000-4,500 crore via local bonds: Report
"Stelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, had worldwide sales of $10.85 billion in 2023.
Read also: Biocon arm receives EMA approval to manufacture biosimilar Bevacizumab at Bengaluru facility
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751