The approved drug is a biosimilar of the reference product Stelara (Ustekinumab).
Ustekinumab, a monoclonal antibody, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA).
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.
In August this year, Biocon Biologics 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 Biologics (BBL) is a fully integrated global biosimilars company and the subsidiary of Biocon.
Biocon is an innovation-led global biopharmaceuticals company engaged in the production of therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small-molecule APIs in India and several key global markets, as well as generic formulations in the US, Europe, & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.
The company reported a consolidated net loss of Rs 16 crore in Q2 FY25 as against a net profit of Rs 126 crore in Q2 FY24. Revenue from operations rose by 4% YoY to Rs 3,590 crore during the quarter.