Biocon Ltd’s biosimilars subsidiary Biocon Biologics Ltd has received marketing authorisation from the European Commission for its biosimilar YESINTEK.
The monoclonal antibody is designed for treating plaque psoriasis, psoriatic arthritis, and Crohn’s disease in both adults and children.
YESINTEK is a biosimilar to Janssen’s Stelara (Ustekinumab) that was approved by the U.S. Food and Drug Administration as far back as 2009.
The EC approval is based on clinical data demonstrating that the biosimilar has comparable safety and efficacy to the original Ustekinumab product.
The medication had received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued in December, the same month the FDA had also approved the biosimilar.
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