Celltrion Healthcare Gains EU Authorization for High-Concentration Adalimumab

Celltrion Healthcare has gained EU marketing authorization for the first high-concentration, citrate-free adalimumab biosimilar, the company said. The company has chosen the brand name Yuflyma for the product, which was referred to as CT-P17 during drug development.

The approval is significant because although the European market already has various adalimumab biosimilars, these are lower volume and contain citrate, which is known to make the administration process painful for patients. In addition, AbbVie, the originator company, has managed to achieve a 60% share of the highly lucrative adalimumab market with its own high-concentration, citrate-free version of adalimumab, so the market is evolving away from the lower-concentration forms, according to the IQVIA Institute for Human Data Science.

Celltrion’s approval gives it the opportunity to be the first to compete in this new market with a lower-cost biosimilar, although the company did not indicate in its press statement the depth of the pricing discount or discounts that would be offered in the European market.

Other advantages of the product are its small or "ultra-fine" needle size, 29 gauge, its latex-free application, and its shelf life of up to 24 months. At room temperature, the biosimilar is stable for up to 30 days, Celltrion said.

“With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least,” Celltrion said HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion.

The biosimilar was approved for patients with 13 chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, pediatric plaque psoriasis, ulcerative colitis, and Crohn disease in both adults and children.

"Features Needed Improvement"

In a statement accompanying the company’s news announcement, a professor of medicine praised the biosimilar as an advantage enabling providers to offer patients a reduction in injection discomfort. “Over the past 2 decades, anti-tumor necrosis factor (TNF) biologics have revolutionized the management of chronic immune-mediated inflammatory diseases, but some of the features needed improvement,” said Professor Rieke Alten, head of the Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology at Schlosspark-Klinik Teaching Hospital of Charite, Berlin, German.

Celltrion aims to take advantage of a rapid approval procedure to get Yuflyma approved in the United Kingdom. The European Commission Decision Reliance Procedure enables automatic submission for UK regulatory approval following EU authorization.

The company said it received EU marketing authorization for Yuflyma based on clinical, preclinical, and analytical studies that demonstrated the biosimilar is comparable to Humira, the reference product, in terms of safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity up to 24 weeks 1 and 1 year following treatment.

Yuflyma is not yet approved in the United States, where there are currently no adalimumab biosimilars on the market.

For a recent interview with Kim about Yuflyma, click here.