Celltrion gets FDA approval for Humira biosimilar CT-P17

South Korean biopharmaceutical company Celltrion Inc. announced on Wednesday that it has obtained product approval from the US Food and Drug Administration for its biosimilar of the autoimmune disease treatment drug Humira (adalimumab) called CT-P17 (brand name: Yuflyma).

As a result, Celltrion will be able to sell Yuflyma for the major indications of Humira, including rheumatoid arthritis and inflammatory bowel disease, starting in July this year.

Humira is an injectable autoimmune disease treatment containing the active ingredient adalimumab, developed by the multinational pharmaceutical company AbbVie in the United States. Yuflyma is a high-concentration formulation in which citrate, which can cause pain, has been removed.

Celltrion plans to secure a market share early on in the US through Celltrion Healthcare, which is responsible for the international supply of Yuflyma. The company also mentioned that global Phase 3 clinical trials are underway to establish compatibility with Humira.

"Through the latest product approval, Yuflyma has the opportunity to establish a leading position as a high-concentration biosimilar of adalimumab in the world's largest market," a Celltrion official said.

According to Celltrion, Humira sales reached $21.2 billion (27.7 trillion won) last year, with over 87% of the sales generated in the US market.

Write to Jeong Min Nam at peux@hankyung.com