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Celltrion Wins Race For High-Concentration Adalimumab

Receives Positive CHMP Opinion For 100mg/ml Biosimilar To Humira

 
• By Dave Wallace

Celltrion expects to receive the world’s first approval for a high-concentration adalimumab biosimilar rival to Humira, after receiving a positive opinion from the EMA’s CHMP for its CT-P17 candidate.

Man Winning Race
Celltrion expects to receive the first approval for a high-concentration adalimumab biosimilar • Source: Shutterstock

Celltrion expects to receive the world’s first approval for a high-concentration biosimilar version of Humira (adalimumab) after receiving a positive opinion recommending granting a pan-European marketing authorization for its CT-P17 candidate from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Assuming approval – the European Commission typically acts on the CHMP’s recommendation within 67 days, with Celltrion indicating that “approval is expected in the first quarter of 2021” – the 100mg/ml formulation would be “the first adalimumab biosimilar with high concentration and citrate-free formulation,” the Korean company confirmed

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