Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200, Biocon’s biosimilar to J&J’s Stelara (ustekinumab), and paves the way for Biocon’s entry into the European, UK, Canadian, and Japanese markets.
Stelara, an interleukin IL-12/23 inhibitor, was first approved in the US in 2009 for the treatment of various autoimmune diseases such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The drug was a significant revenue generator for J&J, with global sales reaching $10.85 billion in 2023. However, the expiration of a key US patent in 2023 prompted J&J to negotiate agreements with several biosimilar manufacturers, including Biocon, to delay the US market launch until 2025. Biocon is currently awaiting approval for Bmab 1200 in the UK, Europe, Canada, and Japan, and the settlement is expected to bolster its existing portfolio of eight biosimilars that are already commercialized in major and emerging markets globally. – Flcube.com
