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Celltrion Healthcare erhält positive Stellungnahme des CHMP der EU für das Adalimumab-Biosimilar CT-P17

Celltrion Healthcare erhält positive Stellungnahme des CHMP der EU für das Adalimumab-Biosimilar CT-P17
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Celltrion Healthcare erhält positive Stellungnahme des CHMP der EU für das Adalimumab-Biosimilar CT-P17

Celltrion Healthcare erhält positive Stellungnahme des CHMP der EU für das Adalimumab-Biosimilar 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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