Celltrion Receives European Approval for High-Concentration Humira Biosimilar 'Yuflyma'

First High-Concentration Formulation of Adalimumab Biosimilar

[Asia Economy Reporter Jihee Kim] Celltrion announced on the 15th that it received marketing authorization from the European Commission (EC) on the 11th local time for the biosimilar of the autoimmune disease treatment Humira (active ingredient adalimumab), ‘CT-P17’. Accordingly, CT-P17 will enter the global market under the brand name ‘YUFLYMA’.

Celltrion had previously received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in December last year. About two months later, it obtained marketing authorization for all indications held by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS).

YUFLYMA is the world’s first high-concentration formulation biosimilar of adalimumab to be introduced to the market. While existing Humira biosimilar products were developed in low concentrations, YUFLYMA reduces the drug dosage by half with its high-concentration formulation and removes citrate, which can cause pain.

The original drug of YUFLYMA, Humira, is an autoimmune disease treatment developed by the US biotech company AbbVie. Its global sales last year reached approximately 22 trillion KRW, ranking first in global sales. Since AbbVie obtained European approval for the high-concentration formulation of Humira in 2015, more than 90% of Humira sold in Europe is reported to be the high-concentration formulation.

YUFLYMA plans to enter the market early by rapidly proceeding with processes such as national drug price listings within Europe through Celltrion Healthcare, which is responsible for global marketing and distribution. Especially as it is the first new-type Humira biosimilar to be introduced in Europe, the company aims to maximize market share before competing products are launched.

A Celltrion official said, "With this EC approval, YUFLYMA’s differentiated competitiveness has been recognized, allowing us to introduce the world’s first new-type Humira biosimilar in Europe." He added, "We plan to supply it promptly to European medical professionals and patients who have been waiting for the new-type Humira biosimilar, providing the benefits of high-quality biopharmaceuticals at a reasonable cost."

This content was produced with the assistance of AI translation services.