Celltrion has recently announced that the US Food and Drug Administration (FDA) has granted item approval to "CT-P17," marketed as Yuflyma, a biosimilar of the autoimmune disease treatment Humira (Adalimumab).
This regulatory approval, received on May 23 in the local time zone, paves the way for the sale of Yuflyma in the United States starting in July.
The biosimilar will be available for the major indications of Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS), effectively establishing Yuflyma as a competitor in the US market for Humira biosimilars. Moreover, Yuflyma's approval signifies its potential dominance in the high-concentration dosage form market due to its unique characteristics.
Yuflyma sets itself apart as a high-concentration formulation that requires only half the drug dosage compared to the low-concentration formulation. Notably, it eliminates the use of citrate, a component known to cause pain. As the market for Adalimumab undergoes a significant shift towards high-concentration formulations, particularly in the US, there is a growing interest in entering the market for biosimilars with such formulations.
Data from US drug market research institutes Symphony Health and IQVIA reveal that approximately 85% of Adalimumab sold in the US last year consisted of high-concentration formulations.
Humira, a highly successful treatment for autoimmune diseases, amassed sales of around $21.237 billion (approximately ₩27.6081 trillion) in the previous year alone. Notably, sales in the US market, considered the largest market for Humira, accounted for approximately $18.619 billion (around ₩24.2047 trillion), representing more than 87% of global sales.
Meanwhile, Celltrion intends to secure an early market share in the United States through its subsidiary, Celltrion Healthcare, responsible for the global supply of Yuflyma. Concurrently, the company aims to enhance Yuflyma's competitive edge by establishing additional differentiating factors.
In pursuit of this goal, Celltrion obtained approval last year for a global Phase 3 clinical trial plan (IND) to demonstrate interchangeability between Yuflyma and Humira. These clinical trials are currently underway in both the US and Europe.
