Biocon Biologics, a subsidiary of Biocon, on Monday announced a strategic out-licensing agreement with Japanese pharmaceutical company Yoshindo to commercialise two of its pipeline biosimilar assets in the Japanese market.

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.

“We are excited to commercialise the two biosimilar products in Japan. This partnership is evidence of our capabilities in R&D, global-scale manufacturing, and quality compliance. Once approved, these products will expand our offering of affordable, quality biosimilars in the Japanese market to address unmet patient needs in the bone health and immunology therapy areas,” said Shreehas Tambe, deputy chief executive officer.

Under the terms of the agreement, Yoshindo will have exclusive marketing rights in Japan for the two biosimilars developed and produced by Biocon Biologics, namely, bUstekinumab, and bDenosumab, with an estimated addressable market opportunity of $700 million, said the company.

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Biocon Biologics said it will receive an upfront licence fee and additional payments upon the achievement of certain development milestones over the next few years. The agreement’s financial details were not made public.

The clinical trials for these two products started in FY22 and include both phase-one and phase-three clinical trials, backed by pre-clinical CMC packages. According to the biotechnology company, it is developing a portfolio of 20 biosimilar assets, both independently and through strategic partnerships.

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