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Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar

Yuflyma 100mg/ml Version Of Adalimumab Ready For Launch In Europe

 
• By Dave Wallace

Celltrion has received a pan-European marketing authorization for its Yuflyma high-concentration adalimumab biosimilar, making it the first firm worldwide to register a 100mg/ml rival to the blockbuster Humira brand.

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Celltrion has the first higher-strength adalimumab biosimilar • Source: Shutterstock

Celltrion has achieved a global first after receiving a marketing authorization for a 100mg/ml biosimilar version of Humira (adalimumab). The European Commission’s pan-European approval follows a positive opinion for the CT-P17 candidate granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use late last year. (Also see "Celltrion Wins Race For High-Concentration Adalimumab" - Generics Bulletin, 11 December, 2020.)

Yuflyma – which will be available as 40mg solution for injection in a pre-filled syringe and pre-filled pen – has been approved for all of Humira’s indications, including rheumatoid arthritis; juvenile idiopathic arthritis; axial spondyloarthritis; psoriatic arthritis; psoriasis; pediatric plaque psoriasis; hidradenitis

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