Celltrion has set out plans to market directly in Europe its subcutaneous version of biosimilar infliximab, after it received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The originator product, Janssen's Remicade, does not come in a subcutaneous formulation, although rival anti-TNF inhibitors including Humira (adalimumab) and Cimzia (certolizumab), do.
While Celltrion’s Remsima version of infliximab is already authorized in the EU as a 100mg powder for concentrate for solution for infusion, the CHMP has recommended changing the terms of the marketing authorization to add a