Celltrion Will Market Subcutaneous Remsima Directly After EU Nod

Celltrion has set out plans to market directly its subcutaneous version of infliximab in Europe. The firm has just received a nod that sets the stage for approval across the EU, albeit with more limited indications than the existing intravenous version.

EMA
The EMA’s CHMP has endorsed Celltrion’s subcutaneous infliximab • Source: Shutterstock

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...

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