Biocon Biologics secures US market entry date for Bmab 1200, a Proposed Biosimilar to Stelara

Bengaluru: Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the Company has signed a settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the United States of America.

The agreement licenses the Company to launch in the United States, in February 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. Biocon Biologics and Janssen have finalized the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US 10961307 before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademarks Office.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “This settlement agreement reflects our commitment and focus on science and innovation. We are pleased that this allows Biocon Biologics to be amongst the first launch group to offer a reliable, high quality biosimilar option to patients and healthcare providers in the United States with our bUstekinumab, Bmab 1200. This development enables Biocon Biologics to build further on our existing immunology franchise in the US. As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products.”

Matthew Erick, Chief Commercial Officer – Advanced Markets, Biocon Biologics Ltd, said, “This agreement for a biosimilar Ustekinumab is an important milestone in our company’s commitment to delivering affordable, life-changing biosimilar medicines. It underscores the Company’s steadfast resolution of supporting the well-being of patients impacted by inflammatory diseases and driving positive change within the healthcare industry.”

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 sales of $7 billion in the United States in 2023.

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