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.
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.

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Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.