Biocon Biologics signs deal with Janssen; The way has been cleared for the launch of biosimilars in America
New Delhi: Biocon Biologics has signed a settlement and license agreement with jansen The biotech and Johnson & Johnson (collectively Janssen) have cleared the way for commercialization of their proposed Bmab 1200. biosimilar Stelara, in the US.
Stelara (ustekinumab) is a monoclonal antibody drug approved to treat psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The reference brand, Stelara, had US sales of $7 billion in 2023.
The agreement licenses the company launch 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 an agreement to dismiss the Inter Partes Review (IPR) pending before the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office.
Shrihas Tambe, CEO and Managing Director, Biocon Biologics, said: “This development enables Biocon Biologics to further expand our existing immunology franchise in the US.”
Stelara (ustekinumab) is a monoclonal antibody drug approved to treat psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The reference brand, Stelara, had US sales of $7 billion in 2023.
The agreement licenses the company launch 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 an agreement to dismiss the Inter Partes Review (IPR) pending before the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office.
Shrihas Tambe, CEO and Managing Director, Biocon Biologics, said: “This development enables Biocon Biologics to further expand our existing immunology franchise in the US.”
