Biocon Biologics gets US market entry date for Bmab 1200, a proposed biosimilar to Stelara

Biocon Biologics has signed a settlement and license agreement with Janssen Biotech, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in the US.

The agreement licenses the company to launch in the US, in February 2025, once approved by the US FDA. The US 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 finalised 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.

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 US in 2023.