Biocon Biologics settles with Janssen; paves way for launch of biosimilar in US

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

Stelara (Ustekinumab) is a monoclonal antibody medication that 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.

The agreement licenses the company to launch the therapy in February 2025, once approved by the USFDA. 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 finalized the settlement agreement to dismiss the pending Inter Partes Review (IPR) before the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademarks Office.

Shreehas Tambe, CEO & managing director, Biocon Biologics said: “This development enables Biocon Biologics to build further on our existing immunology franchise in the US''.