Bengaluru: Biocon Biologics Ltd (BBL), a biosimilars company and a subsidiary of Biocon Ltd, announced that it has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize its psoriasis drug, Bmab 1200, in Europe, particularly the United Kingdom (UK), Canada, and Japan.
Under the terms of the settlement agreement, the biosimilar company has resolved patent disputes with Janssen to secure market entry dates in the aforementioned markets, while the regulatory filings for the drug are currently under review, the company stated in a release.
“This settlement agreement 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 Ltd, said.
Bmab 1200 is a proposed biosimilar to Stelara (Ustekinumab), a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated with immune diseases. It has been approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, according to the release.
According to Johnson & Johnson’s reported sales figures for 2023, Stelara registered global sales of $10.85 billion.
Notably, Biocon had earlier announced a settlement agreement in the United States for the same drug, with a planned launch no later than February 22, 2025, pending approval by the U.S. FDA. The regulatory authority has accepted the company’s Biologics License Application (BLA) for review under the 351(k) pathway.
