Biocon’s arm secures approval from PMDA for Ustekinumab BS subcutaneous injection

07 Jan 2025 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has received an approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for Ustekinumab BS subcutaneous injection [YD], a biosimilar to the reference product, Stelara (Ustekinumab). The biosimilar Ustekinumab has been developed and manufactured by the Company and will be commercialized and marketed in Japan by the Company’s exclusive commercial partner, Yoshindo Inc.

Ustekinumab, a monoclonal antibody, is approved for the treatment of Psoriasis Vulgaris and Psoriatic Arthritis (PsA). Biocon Biologics previously notified the Stock Exchange on August 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize Ustekinumab in Japan, upon regulatory approval.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


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