Celltrion wins US FDA approval for Yuflyma pediatric use

Korean biosimilar giant Celltrion announced Monday it has received additional approval from the US Food and Drug Administration for pediatric use of its autoimmune disease treatment, Yuflyma, offering new options for children with limited options.

There are two indications being added this time: pediatric uveitis, an inflammatory eye disease, and hidradenitis suppurativa, a chronic skin disease.

Celltrion increased its market share in the market by obtaining permission when the exclusive right for the pediatric indications of the original drug, Humira, expired. As a result, pediatric patients enjoy the same treatment benefits as Humira at a more reasonable price.

Yuflyma is a high-concentration biosimilar of Humira, developed after the original patent expired. Its key features include half the dosage concentration of the low-concentration version and the removal of citrate, an ingredient that can cause pain during injection.

The company plans to expand its distribution channels in the US using a dual-pricing policy, which sets different prices for public and private insurance markets. This strategy, combined with Yuflyma's competitiveness, is intended to increase its profitability and market share in the US, the world's largest drug market.

Humira, the original biologic, recorded substantial global sales last year, including 12.68 trillion won ($8.9 billion) worldwide, with over 79 percent of those sales — 10.15 trillion won — from the United States.

"The additional acquisition of Yuflyma pediatric indications is expected to provide new treatment options for pediatric patients in the US, which should lead to increased prescriptions in the medical field," said an official from Celltrion.