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NEW DELHI: Biocon Biologics has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company, Yoshindo Inc., for commercialising bUstekinumab and bDenosumab, two of its biosimilar assets in the pipeline, in the Japanese market.

As part of the agreement, Yoshindo will get exclusive commercialisation rights in Japan for bUstekinumab and bDenosumab, developed and manufactured by Biocon Biologics, for an addressable market opportunity of over $700 million.

Shreehas Tambe, deputy chief executive officer, said, “We are excited to partner with Yoshindo to commercialise 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 programmes 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 pre-clinical CMC packages," the company said in a statement.

Biocon Biologics, part of pharma major Biocon Ltd., will receive an upfront licence fee as well as additional payments on the achievement of certain development milestones over the next few years. The financial terms of the agreement were not disclosed.

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.

ABOUT THE AUTHOR

Priyanka Sharma

Priyanka Shamra is a health and pharma journalist with nearly nine years of field reporting experience. She is a special correspondent with Mint. Her beat includes covering the Ministry of Health and Department of Pharmaceuticals. She also covers the Ministry of Women and Child Development and the Department of Biotechnology.
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