Celltrion secures EU approval for its adalimumab biosimilar

Celltrion secures EU approval for its adalimumab biosimilar


Celltrion secures EU approval for its adalimumab biosimilar
Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
CT-P17 is the first approved adalimumab biosimilar in the EU with a high concentration, low-volume, and citrate-free formulation. Such formulations area said to reduce injection discomfort.
The EC approval of Yuflyma follows the recommendation for marketing authorization issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December last year.
In terms of the administration device, Dr HoUng Kim, head of the medical and marketing division at Celltrion Healthcare, said the South Korean company looked to ensure improved convenience for patients in terms of the administration device - it includes a proper needle size (29G), it is latex-free, which can reduce allergy risk, and the product has a long storage period or shelf life at room temperature.  

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