Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo for commercializing two of its pipeline biosimilar assets, bUstekinumab and bDenosumab, in the Japanese market.

Under the terms of this deal, Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics, for an addressable market opportunity of around US $700 million. 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. The financial terms of the agreement are confidential.

Ustekinumab, 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. Denosumab, a biosimilar referencing Prolia, is a monoclonal antibody for the treatment of osteoporosis.

Shreehas Tambe, Deputy Chief Executive Officer said, “We are excited to partner with Yoshindo to commercialize two of our pipeline biosimilar products, bUstekinumab and bDenosumab, in Japan. This partnership is testament to Biocon Biologics’ proven capabilities in R&D, global scale manufacturing and quality compliance. Once approved, these products will expand our offering of affordable, high quality biosimilars in the Japanese market and help address unmet patient needs in bone health and immunology therapy areas.”

The strategic partnership with Yoshindo will build upon Biocon Biologics’ successful progress in its global development programs for these two biosimilar assets. Clinical trials for these two assets commenced in FY22 and include both Phase 1 and Phase 3 clinical trials backed by robust preclinical CMC packages.

To provide patients access to affordable biologics and enable health equity, Biocon Biologics 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.