Celltrion files for biosimilar’s FDA interchangeable designation

Yuflyma [Courtesy of Celltrion]

South Korea’s Celltrion Inc. announced on Wednesday that it has applied for a modified approval with the U.S. Food and Drug Administration (FDA) to obtain interchangeability between its autoimmune disease treatment biosimilar ‘Yuflyma’ and the original product in the United States.

Yuflyma is a biosimilar to ‘Humira’, an autoimmune disease treatment for rheumatoid arthritis, spondyloarthritis, psoriasis, and other conditions. It is currently being supplied after winning its U.S. sales authorization in 2023.

If a biosimilar product is deemed interchangeable with the generic product in the United States, it can be substituted at pharmacies without involving doctors, thus securing market competitiveness. Many biosimilar developers are conducting clinical trials not only for approval but also to confirm interchangeability with the generic drug and are applying for modified approvals.

Celltrion previously demonstrated that Yuflyma and Humira are statistically equivalent in a Phase 3 clinical trial on interchangeability involving 367 patients with moderate to severe plaque psoriasis. The company expects that gaining interchangeability recognition will positively impact Yuflyma’s market share expansion in the United States.

“Once the modified approval for interchangeability is completed in the United States, we can expect a bigger market share in the world’s largest market, which is becoming more favorable to biosimilars,” a Celltrion official said. “We will do our utmost to secure the interchangeable designation.”