Biocon Biologics Ltd., a subsidiary of Bangalore, India-headquartered Biocon Ltd., announced a strategic out-licensing agreement with Japan-based pharmaceuticals company Yoshindo Inc., for commercializing two of its pipeline biosimilar assets.
Under the terms of this deal, Biocon Biologics will receive an upfront license fee as well as additional payments on the achievement of certain development milestones over the next few years. Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab — both developed and manufactured by Biocon Biologics — for an addressable market opportunity of $700 million.
bUstekinumab, a biosimilar referencing Stelara, is a monoclonal antibody used to treat several autoimmune conditions, including psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. bDenosumab, a biosimilar referencing Prolia, is a monoclonal antibody for the treatment of osteoporosis.
Clinical trials for these two assets commenced in FY22 and include both Phase 1 and Phase 3 clinical trials backed by robust pre-clinical CMC packages.
To provide patients access to affordable biologics and enable health equity, the company is developing a broad portfolio of 20 biosimilar assets either independently or through strategic partnerships. Biocon Biologics became the first company from India to commercialize a biosimilar in Japan after its Insulin Glargine was successfully launched in Japan by another partner in 2016.
