EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara

Biocon

15 December 2024 - Biocon Biologics today announced that the EMA’s 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 – based on the application filed by Biosimilar Collaborations Ireland, an indirect wholly owned subsidiary of Biocon Biologics.

Clinical studies showed that the ustekinumab biosimilar has a similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with the originator product.

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Michael Wonder

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Michael Wonder