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European agency endorses approval of Biocon Biologics' biosimilar Ustekinumab
The New Indian Express Hubballi
|December 17, 2024
BIOCON BIOLOGICS, a biosimilars company and subsidiary of Biocon, has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESINTEK, an Ustekinumab biosimilar intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.
It said clinical studies showed the Ustekinumab biosimilar has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with the originator product.
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