Celltrion Healthcare launches Humira biosimilar Yuflyma in US

South Korean biopharmaceutical company Celltrion Healthcare on Monday said it launched the day before on the US market Yuflyma, a biosimilar of the autoimmune disease treatment Humira, with the former's active ingredient being adalimumab-aaty.

Humira is a blockbuster drug with global sales last year of $21.2 billion (27.4 trillion won), 87% or $18.6 billion of which came from the US. Available in autoinjector and prefilled syringe form, the treatment has secured indications in America for eight diseases including rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

Celltrion Healthcare set the wholesale acquisition cost of Yuflyma at $6,576.5 per two doses, 5% cheaper than Humira. The company is negotiating with many prescription benefit management companies under a goal of entering the American insurance market, which covers 40% of the country's population.

A high-concentration medicine of 100 milligrams per milliliter that halves dosage from its low-concentration counterparts, Yuflyma has no citrate, which can cause pain. In addition, it can be safely used for up to 30 days if stored at room temperature of 25 degrees Celsius, boasting a shelf life over twice as long as Humira's.

The removal of latex from the biosimilar also prevents allergies to ensure patient convenience and safety.

Celltrion Healthcare is conducting Phase 3 clinical trials worldwide to secure Yuflyma's interchangeability with original treatments in the US and Europe, and completion is slated for the end of next year. The company will also expand prescriptions for the biosimilar by raising its competitiveness.

From Monday, the company's American subsidiary Celltrion USA will launch for patients and medical personnel the Celltrion Connect Patient Support Program, which supports copays and products for uninsured patients or those with insufficient coverage if they meet the conditions.

Write to Ye-Na Kim at yena@hankyung.com