EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

The European Commission (EC) has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17), for all 13 intended indications for the treatment of multiple chronic inflammatory diseases.

Celltrion Healthcare revealed the authorization notice in a Feb. 15, 2021 press release, in which the company stated that the approval had been based on the results of analytical, preclinical, and clinical studies that demonstrated that Yuflyma is comparable with adalimumab. The EC’s approval follows the recommendation for marketing authorization that had been issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was issued in December 2020.

“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, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “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 added in the press release, “Over the past two decades, anti-tumor necrosis factor (TNF) biologics have revolutionized 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.”

Source: Celltrion Healthcare