On 15 December 2024, Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of Yesintek®, biosimilar to Janssen’s Stelara®, for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. CHMP’s positive opinion follows the recent FDA approval earlier this month for Yesintek® for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
On 16 December 2024, it was reported that the European Commission had granted marketing authorisation for Accord Healthcare’s Imuldosa®, biosimilar ustekinumab, for a range of immune medicated inflammatory diseases. Imuldosa® was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals. Through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada, Imuldosa® will be launched in multiple regions.
On 17 December 2024, Celltrion announced that the US FDA had approved Steqeyma®, biosimilar ustekinumab, for the treatment of adult and paediatric patients with plaque psoriasis and active psoriatic arthritis as well as adults with Crohn’s disease and ulcerative colitis.