EU approves Yuflyma for multiple chronic inflammatory diseases – Celltrion Healthcare

Celltrion Healthcare announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.

The EC approval of Yuflyma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2020. The marketing authorisation is based on analytical, preclinical and clinical studies, demonstrating that Yuflyma is comparable to adalimumab, the reference product, in terms of safety, efficacy, PK/PD and immunogenicity up to 24 weeks and 1 year following treatment. Based on the results of the pivotal study, a high concentration formulation of Yuflyma has been approved for use in the European Union (EU), in patients with thirteen chronic inflammatory diseases; rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV).

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