 "Biocon Biologics")
Biocon arm Biocon Biologics on Thursday said it has signed a settlement and license agreement with Janssen Biotech Inc, and Johnson & Johnson (collectively known as Janssen) that clears the path to commercialise Bmab 1200, a proposed biosimilar to Stelara in the US.
Stelara is approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis which had sales of $7 billion in the United States in 2023.
The agreement licenses the Biocon Biologics to launch in the USA, in February 2025, once approved by the USFDA (Food and Drug Administration).
Biocon said the USFDA has accepted Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon Biologics and Janssen have finalised the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademarks Office.
“This settlement agreement reflects our commitment and focus on science and innovation. We are pleased that this allows Biocon Biologics to be among 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,” said Shreehas Tambe, chief executive officer and managing director, Biocon Biologics.
“This development enables Biocon Biologics to build further on our existing immunology franchise in the US. As a fully integrated biosimilars firm, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products,” Tambe added.
Stelara (Ustekinumab), a monoclonal antibody medication that prevents abnormal regulation of interleukin-associated immune diseases, was approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
