Biocon Biologics Secures US Entry Date For Bmab 1200, A Stelara Biosimilar
Biocon Biologics (BBL), a global biosimilar company and a subsidiary of Biocon, has inked a settlement and license agreement with Janssen Biotech Inc. and Johnson and Johnson, collectively known as Janssen. In a press statement on Thursday, the company said that this move paves the way for the commercialisation of Bmab 1200, a proposed biosimilar to Stelara, in the United States.
Under the agreement, Biocon Biologics is licensed to launch Bmab 1200 in the United States, scheduled for February 2025, subject to approval by the U.S. FDA. The 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 also settled 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 and Managing Director of Biocon Biologics expressed, “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 groups 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."
Matthew Erick, Chief Commercial Officer – Advanced Markets, Biocon Biologics, added, "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 approved for various immune diseases. The reference brand, Stelara, achieved sales of USD 7 billion in the United States in 2023.
