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Celltrion's inflammatory disease drug Yuflyma gets EU approval for 13 indications

Published on 16/02/21 at 10:14am

The European Commission (EC) has granted marketing authorisation for Celltrion’s Yuflyma, an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.

The EC’s approval of Yuflyma follows the recommendation for marketing authorisation issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in December, and is based on studies demonstrating that Yuflyma is comparable to adalimumab, the reference product, in terms of safety, efficacy, pharmacokinetic/pharmacodynamic modelling, and immunogenicity up to one year following treatment.

Based on the results of the pivotal study, a high concentration formulation of Yuflyma has been approved for use in EU patients with thirteen chronic inflammatory diseases; rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis, and paediatric uveitis.

The marketing authorisation is valid in all 27 EU member states, as well as in the European Economic Area countries Iceland, Liechtenstein, and Norway. The EC’s approval will enable affordable access to a high concentration adalimumab biosimilar, broadening treatment alternatives for patients suffering with chronic inflammatory disease.

Celltrion will take the EC Decision Reliance Procedure (ECDRP) to minimise lead time to launch the product in the UK.

Dr HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare, said: “In Europe, according to IQVIA data, 60% of the whole adalimumab market has been taken by high concentration formulation and over 90% of the original adalimumab market has already been replaced with a high concentration version.

“With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we focused on development of a high concentration biosimilar to provide a significant alternative to the adalimumab treatment category.”

Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité in Berlin, Germany, also commented: “Over the past two decades, anti-tumour necrosis factor biologics have revolutionised the management of chronic immune-mediated inflammatory diseases, but some of the features needed improvement for patients to reach their therapeutic goals.

“As a physician, we welcome these value-added features such as high concentration and low-volume formulations to reduce injection discomfort.” 

Darcy Jimenez

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