Celltrion’s Humira biosimilar bags FDA approval to treat autoimmune diseases

Celltrion said on Wednesday that its Humira biosimilar, Yuflyma (ingredient: adalimumab) a biosimilar to treat autoimmune diseases, obtained marketing approval from the U.S. FDA.

With this approval, Yuflyma will be available in the U.S. in July for key indications covered by the original drug Humira such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS).

This now places Yuflyma in an advantageous position to capture the U.S. market for Humira's biosimilar high-concentration formulation, said a Celltrion official.

Yuflyma is a high-concentration formulation that halves the drug dose compared to the low-concentrations and eliminates citrate, which can cause pain.

The market for adalimumab is rapidly shifting to higher concentrations, especially in the U.S., and interest is growing in biosimilars of higher concentrations. According to Symphony Health and IQVIA, high-concentration formulations accounted for approximately 85 percent of adalimumab sold in the U.S. last year.

AbbVie’s Humira is a blockbuster autoimmune disease treatment that generated sales of about $21.37 billion last year. The U.S. market alone accounted for more than 87 percent of global sales of approximately $18.619 billion.

"This approval paves the way for Yuflyma to secure a leading position as a high-concentration biosimilar in the U.S. which stands as the largest market for adalimumab," said a Celltrion official. "We will do our best to establish an early presence in the U.S. market with differentiated competitiveness through discussions with Celltrion Healthcare."

In this regard, the company obtained approval last year for a global phase 3 study to establish interchangeability between Yuflyma and Humira in the U.S. and Europe, and clinical trials are currently ongoing.