Celltrion gains EC clearance for its biosimilar Yuflyma

Celltrion Healthcare (Kosdaq: 068270) revealed yesterday that the European Commission (EC) has granted marketing authorization for Yuflyma (CT-P17), an adalimumab biosimilar, across all 13 intended indications for the treatment of multiple chronic inflammatory diseases.

The approval follows a European Medicines Agency advisory panel recommendation in December that Yuflyma, referencing AbbVie’s (NYSE: ABBV) mega blockbuster Humira, be approved for the treatment of certain inflammatory and autoimmune disorders.

The marketing authorization is based on analytical, pre-clinical 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 13 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), pediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), pediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and pediatric uveitis (pUV).