Celltrion "Uplima Applies for Interchangeable Change Approval with Humira in the US"

Entered FDA approval process to secure high-concentration interchangeability status
Efforts to expand 24 trillion Humira market share

Celltrion announced on the 10th that it has submitted a supplemental application to the U.S. Food and Drug Administration (FDA) to secure interchangeability between its autoimmune disease treatment 'Yuflyma' and the original drug 'Humira.'

Based on the results of the global Phase 3 clinical trial conducted to obtain interchangeability approval for Yuflyma, Celltrion applied for a supplemental approval to allow interchangeability with Humira.

Previously, Celltrion conducted a global clinical trial involving 367 patients with moderate to severe plaque psoriasis and demonstrated statistical equivalence and safety between the multiple-switch treatment group of Yuflyma and Humira and the Humira maintenance treatment group.

Celltrion expects that recognizing the interchangeability between Yuflyma and Humira through this supplemental approval will have a positive impact on expanding Yuflyma's market share in the United States. Securing interchangeability status means that Yuflyma can be prescribed at pharmacies with the same efficacy and safety as the original drug without physician intervention.

Yuflyma, developed by Celltrion, is the first high-concentration Humira biosimilar, characterized by reducing the drug dosage by half compared to the low concentration version and removing citrate, which can cause pain.

Celltrion has obtained marketing approval for Yuflyma from the European Medicines Agency (EMA) and the U.S. FDA for indications including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PsO), and is currently supplying the product. In September last year, it additionally obtained FDA approval for Yuflyma's dosage forms, completing a lineup of three high-concentration adalimumab products.

The original drug of Yuflyma, Humira, is a blockbuster autoimmune disease treatment that recorded sales of approximately $21.237 billion (about 27.6081 trillion KRW) in 2022. Notably, in the United States, considered the largest market, it recorded sales of about $18.619 billion (approximately 24.2047 trillion KRW), accounting for more than 87% of global sales.

A Celltrion official stated, "Once the supplemental approval to secure interchangeability between Yuflyma and Humira in the U.S. is completed, we can expect a steeper market share expansion in the U.S., the world's largest market, where a favorable environment for biosimilar expansion is being formed."

This content was produced with the assistance of AI translation services.