Biocon Biologics Yesintek gets European Commission approval for plaque psoriasis, psoriatic arthritis
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for YESINTEK, a biosimilar of Ustekinumab.
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.
Clinical data from the trial program showed that Ustekinumab biosimilar has comparable safety and efficacy to the originator product. The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued on December 14, 2024.
Medical Dialogues team had earlier reported that Pharmaceuticals and Medical Devices Agency (PMDA) of Japan had approved Ustekinumab BS subcutaneous injection [YD], a biosimilar to the reference product, Stelara (Ustekinumab).
Read also: Biocon Biologics gets Japenese nod for Psoriasis Vulgaris injection Ustekinumab BS
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company. The Company has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
Read also: Biocon likely to list key biosimilars business by March 2026
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