Biocon Biologics gets Japenese nod for Psoriasis Vulgaris injection Ustekinumab BS
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has approved 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).
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Biocon Biologics had previously 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.
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