October 17, 2022: Biocon Biologics, a subsidiary of India’s Biocon, has inked an out-licencing pact with Japan’s Yoshindo Inc for selling two biosimilars.
The products, bUstekinumab and bDenosumab, will be sold in the Japanese market, and Yoshindo will get exclusive commercialization rights for the two products made by Biocon Biologics.
Ustekinumab, a biosimilar referencing Stelara, is a monoclonal antibody used to treat several autoimmune conditions. It includes 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.
Clinical trials for these assets commenced in the last fiscal year and included phase 1 and 3 clinical trials backed by pre-clinical chemistry manufacturing and control packages.
The addressable market opportunity in Japan is about $700 million, according to a BSE filing.
“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 filing stated.
The company did not disclose the financials of the agreement.
“Once approved, these products will expand our offering of affordable, high-quality biosimilars in the
Japanese market,” Shreehas Tambe, Deputy Chief Executive Officer, said.
It will “help address unmet patient needs in bone health and immunology therapy areas,” he said.
Biocon Biologics is developing a broad portfolio of 20 biosimilar assets independently or through strategic partnerships.
The Bengaluru-based 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