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Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)

Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)
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Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17

Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases
The positive opinion is based on Phase I/III study data investigating the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety
If approved, CT-P17 would be the first adalimumab biosimilar with high concentration (100mg/mL) and citrate-free formulation
Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of an adalimumab biosimilar candidate referencing Humira ....

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