Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions.  STEQEYMA is a human IL-12 and IL-23 antagonist indicated for multiple immune-mediated diseases.  It is available in both subcutaneous and intravenous forms.  The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe.  The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.  This EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024.

Approval of Henlius’s Trastuzumab Biosimilar in Canada:  On August 22, 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, a biosimilar of Roche’s HERCEPTIN (trastuzumab), for the treatment of early/metastatic breast cancer and metastatic gastric cancer.  HLX02 is marketed in Canada under the name ADHEROZA.

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