Biocon Biologics settles with Janssen; paves approach for launch of biosimilar in US – Occasions of India

NEW DELHI: Biocon Biologics has signed a settlement and license settlement with Janssen Biotech and Johnson & Johnson (collectively Janssen) that clears the best way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, within the US.
Stelara (Ustekinumab) is a monoclonal antibody treatment that has been permitted for the therapy of psoriasis, Crohn’s illness, ulcerative colitis, plaque psoriasis and psoriatic arthritis.The reference model, Stelara, had gross sales of $7 billion within the US in 2023.
The settlement licenses the corporate to launched the remedy in February 2025, as soon as permitted by the USFDA. The US FDA has accepted the corporate’s Biologics License Utility (BLA) for Bmab 1200 (bUstekinumab) for evaluation beneath the 351(okay) pathway.
Biocon Biologics and Janssen have finalized the settlement settlement to dismiss the pending Inter Partes Evaluation (IPR) earlier than the Patent Trial and Enchantment Board (PTAB) of the US Patent and Emblems Workplace.
Shreehas Tambe, CEO & managing director, Biocon Biologics mentioned: “This improvement allows Biocon Biologics to construct additional on our present immunology franchise within the US”.