Biocon Biologics on Monday announced that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo Inc. for commercialising two of its pipeline biosimilar assets, bUstekinumab, and bDenosumab, in the Japanese market.
The company announced that as a part of this deal, Yoshindo gets exclusive commercialisation rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics, for an addressable market opportunity of approximately USD 700 million.
Biocon Biologics also claimed that it 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, it stated.
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. Meanwhile, Denosumab, a biosimilar referencing Prolia, is a monoclonal antibody for the treatment of osteoporosis.
“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,” Shreehas Tambe, Deputy Chief Executive Officer, Biocon Biologics, said in a statement.
The company also claimed that a 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 FY-22 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, Biocon Biologics is developing a broad portfolio of 20 biosimilar assets either independently or through strategic partnerships,” the company stated.
Reportedly, 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.
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