Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)

Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma^TM (CT-P17)

• Yuflyma™ (CT-P17) is the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation; 60% of adalimumab market captured by high concentration formulation in Europe according to IQVIA
• Yuflyma™ is approved in all intended indications for the treatment of multiple chronic inflammatory diseases
• Yuflyma™ has 29G needle size, latex-free device, and a shelf-life up to 24 months (2-8℃); at room temperature Yuflyma™ is stable up to 30 days

MONDAY 15 FEBRUARY, 2021 - INCHEON, SOUTH KOREA - Celltrion Healthcare today 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^[i] and 1 year^[ii] 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).

“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,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “In terms of the administration device, we have looked to ensure improved convenience for patients as well as providers with the inclusion of needle size (29G), latex-free to reduce allergy risk, and a long storage period or shelf life at room temperature for 30 days.”

Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany said, “Over the past two decades, anti-tumour necrosis factor (TNF) 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.” 

The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway. This announcement will enable affordable access to a high concentration adalimumab biosimilar, broadening treatment alternatives for patients suffering with chronic inflammatory disease including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis.

Celltrion will take the EC Decision Reliance Procedure (ECDRP) to minimise lead time to launch the product in the UK and remains committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies.

[i] J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020

[ii] Data on file