The European Commission (EC) has approved Yuflyma (CT-P17), an adalimumab biosimilar, to treat multiple chronic inflammatory diseases, including juvenile idiopathic arthritis.
Similar to generics, biosimilars are products that have identical pharmacological properties and are as safe and effective as the original brand-name medications they are based on. However, they tend to be less expensive than their reference products.
With this decision, patients with chronic inflammatory disorders living in Europe will now have access to an alternative to adalimumab (sold as Humira by AbbVie) to manage their condition.
Developed by Celltrion Healthcare, Yuflyma is the first adalimumab biosimilar to use a high concentration, low-volume, citrate-free formulation, meaning that it is designed to cause less pain when injected. The medication also comes with a latex-free injectable device equipped with a thin needle to reduce allergy risk, and to make treatment administration easier for both patients and healthcare providers.
According to Celltrion, Yuflyma can safely be stored at room temperature for 30 days, and if kept in a cold environment can last up to two years.
“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,” HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion Healthcare, said in a press release.
The EC’s decision to approve Yuflyma, making it available in all European Union countries along with Iceland, Liechtenstein, and Norway, was announced around two months after the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), recommended its approval.
That opinion was supported by preclinical and clinical studies showing the medication has similar pharmacological properties and is as safe and effective as Humira when given up to one year.
Like adalimumab, Yuflyma is now approved to treat 13 different types of chronic inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis (two forms of inflammatory bowel disease), psoriatic arthritis, psoriasis, and uveitis.
Celltrion is planning to take advantage of the EC Decision Reliance Procedure — a new regulatory route that quickens the U.K launch of medications approved via a centralized procedure in Europe.