Celltrion's autoimmune drug gets approval for EU sales

Celltrion's biosimilar CT-P17 was approved for sale in Europe, the company said Monday.

The final nod from the European Commission came on Feb. 11. CT-P17 is a biosimilar of Abbvie's Humira, or adalimumab.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

CT-P17 will be sold under the brandname "Yuflyma." It is Celltrion's fourth biosimilar to start selling overseas following Remsima, Truxima and Herzuma. Distribution of Yuflyma in European countries will be handled by the company's affiliate Celltrion Healthcare.

In Europe, Humira is prescribed as a treatment for autoimmune diseases including rheumatoid arthritis and Crohn's disease. Last year, Humira's sales were $19.8 billion worldwide, making it one of the top selling drugs in the world. Celltrion said CT-P17 received approval for all of Humira's 13 indications for medical use.

Among Humira biosimilars, CT-P17 is the first high-concentration formulation to receive approval from a drug administrator. High-concentration means that patients can take a half dose compared to competitors.

"According to IQVIA data, 60 percent of the adalimumab market has been taken by high concentration formulation and for Humira, over 90 percent was already captured by a high concentration version," said Dr. Kim Ho-ung, head of the medical and marketing at Celltrion Healthcare.

"With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we thought a high concentration version has the potential to dominate the adalimumab category as long as we maintain parity in the price range compared with low concentration versions."

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]