Celltrion Adds Two High-Concentration Versions of Humira Biosimilar 'Yuflyma' Approved in the US

Approval Added for 80mg·20mg Dosage Forms... Securing 3 High-Concentration Types
Accelerating Entry into the 27 Trillion Won Market

Celltrion announced on the 4th that it had additionally obtained approval from the U.S. Food and Drug Administration (FDA) on the 29th of last month (local time) for the 80mg/0.8ml and 20mg/0.2ml (hereinafter 80mg, 20mg) dosage forms of the Humira (active ingredient adalimumab) biosimilar 'Yuflyma.'

Biosimilar of the autoimmune disease treatment Humira, 'Yuflyma' is a US product.
[Photo by Celltrion]

With the addition of these two dosage forms of Yuflyma, Celltrion now has a lineup of three high-concentration adalimumab dosage forms, including the existing 40mg/0.4ml. The company explained that by securing not only the advantage of a high-concentration biosimilar formulation but also dosage form differentiation, its competitiveness in the U.S. market has been strengthened. Through this, it plans to accelerate market penetration.

Celltrion expects that the addition of these two high-concentration adalimumab dosage forms will contribute to creating a prescription environment that meets the needs of patients and healthcare professionals. For patients requiring high-dose administration depending on the indication, the 80mg prescription can reduce the frequency of administration, and for pediatric patients requiring low-dose administration, the 20mg prescription is now possible, thereby increasing preference and convenience through customized prescriptions.

Yuflyma is characterized by a high-concentration formulation that reduces the drug administration volume by half compared to low concentration and removes citrate, which can cause pain. The major global adalimumab markets have already been reorganized around high-concentration formulations, and especially in the U.S., prescriptions for high-concentration formulations with high dosing convenience are common, according to the company. According to U.S. pharmaceutical market research firms Symphony Health and IQVIA, as of last year, more than 85% of adalimumab sold in the U.S. consists of high-concentration formulations.

Yuflyma not only secures three different dosage forms but also offers both auto-injector (AI) and prefilled syringe (PFS) formulations. Celltrion anticipates that this will broaden the range of applicable patients and positively impact sales and market share expansion in the U.S.

The original drug of Yuflyma, Humira, is a blockbuster autoimmune disease treatment sold by AbbVie in the U.S., recording sales of approximately $21.237 billion (about 27.6081 trillion KRW) last year. In particular, the U.S. market, considered the largest, accounted for more than 87% of global sales, approximately $18.619 billion (about 24.2047 trillion KRW).

Celltrion plans to actively expand its market influence by securing differentiated competitiveness compared to other companies in the adalimumab market. To this end, it plans to complete the global Phase 3 interchangeability clinical trial between Yuflyma and Humira, which is currently underway after receiving Investigational New Drug (IND) approvals in the U.S. and Europe, within this year and proceed with sequential approval procedures.

Additionally, Celltrion has signed a contract with U.S. biotech company Lani Therapeutics for the development of oral adalimumab and has secured priority negotiation rights for global development and sales rights upon successful development. Both companies plan to improve patient dosing convenience and expand market influence.

A Celltrion official said, "There are not many companies holding high-concentration biosimilars with various dosage forms such as 80mg, so Yuflyma's competitiveness in the U.S. adalimumab market, which centers on high-concentration formulations, will grow even stronger," adding, "We will do our best to provide differentiated, high-quality biopharmaceuticals to more U.S. healthcare professionals and patients."

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