South Korean biopharmaceutical company Celltrion Healthcare has secured European Commission (EC) marketing authorisation for the sale of Yuflyma (CT-P17) for the treatment of multiple chronic inflammatory diseases.
Yuflyma is said to be the first adalimumab biosimilar with a low-volume, high concentration and citrate-free formulation.
EC approval follows the recommendation for marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in December last year.
The biosimilar adalimumab is approved for the treatment of patients with 13 chronic inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
It also includes pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis and paediatric uveitis.
Yuflyma was approved based on analytical, preclinical and clinical studies for the treatment of multiple chronic inflammatory diseases.
Celltrion Healthcare Medical and Marketing Division head HoUng Kim 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.”
The company stated that the adalimumab biosimilar has a 29G needle size, is a latex-free device to reduce allergy risk, and has a shelf-life of up to 24 months with room temperature stability up to 30 days.
As per the EC authorisation, Yuflyma can be sold in all EU Member States as well as in the European Economic Area countries including Iceland, Liechtenstein and Norway.