Celltrion Healthcare Launches 'Yuflyma' in the US, the Largest Market for Humira

Humira Biosimilar Uplyma
Full Launch in the US, the World's Largest Adalimumab Market
High-Concentration Formulation Free of Citrate and Latex

Celltrion Healthcare announced on the 3rd that it launched the Humira biosimilar for autoimmune disease treatment, 'Yuflyma (generic name: adalimumab),' in the United States on the 2nd (local time).

Celltrion's Humira biosimilar 'Yuflyma' product in the United States. [Photo by Celltrion Healthcare]

The original product of Yuflyma, Humira, is a blockbuster drug that recorded sales of approximately $21.237 billion (about 27.4425 trillion KRW) last year, with sales in the U.S. alone exceeding 87%, reaching about $18.619 billion (approximately 24.0595 trillion KRW). Yuflyma has secured indications for a total of eight diseases in the U.S., including rheumatoid arthritis (RA), Crohn's disease (CD), and ulcerative colitis (UC). The formulation was launched in two types: an auto-injector and a prefilled syringe (PFS).

Celltrion Healthcare announced that the wholesale acquisition cost (WAC) of Yuflyma was set at $6,576.5 (based on two doses), which is a 5% discount compared to the original product. Furthermore, considering the characteristics of the U.S. pharmaceutical market, where inclusion in insurance formularies and preferred drug lists is key to expanding market share, the company is currently negotiating with multiple Pharmacy Benefit Managers (PBMs) linked to these formularies and aims to be listed in insurance plans covering 40% of the U.S. population.

Celltrion Healthcare emphasized that it expects to achieve success in the U.S. adalimumab market based on Yuflyma's product competitiveness. First, Yuflyma features a high-concentration (100 mg/mL) formulation that reduces the drug dose by half compared to low concentration and removes citrate, which can cause pain. According to the pharmaceutical market research firm Symphony Health, as of May, the high-concentration formulation accounts for 86.7% of the U.S. adalimumab market, indicating that the U.S. market is predominantly high-concentration formulations.

Additionally, Yuflyma can maintain stability at room temperature (25℃) for up to 30 days with a shelf life more than twice as long as the original product, and it prevents allergies by removing latex (natural rubber). Along with this, a global Phase 3 clinical trial aimed at securing interchangeability with the original drug is underway in the U.S. and Europe, targeting the end of 2024, which will further strengthen product competitiveness and promote the expansion of Yuflyma prescriptions.

Professor Jonathan Kay of the University of Massachusetts Medical School stated, "Among the adalimumab biosimilars approved by the U.S. Food and Drug Administration (FDA), few have both a citrate-free and high-concentration formulation, but Yuflyma, which has both, has now been launched in the U.S. market." He added, "Yuflyma can reduce the discomfort caused by administration for patients with chronic diseases such as rheumatoid arthritis, thereby improving treatment adherence."

Thomas Nussbickel, Chief Commercial Officer (CCO) of Celltrion Healthcare's U.S. subsidiary, said, "The launch of Yuflyma will be a significant milestone not only for Celltrion Healthcare but also for patients, healthcare professionals, payers, and all stakeholders connected to the U.S. bioindustry." He added, "We plan to conduct various marketing activities for patients across the United States." He continued, "Having the competitive strength to successfully launch various drugs globally, including the world's first antibody biosimilar Remsima, we will actively utilize the commercial capabilities of our local subsidiary to lead the expansion of Yuflyma prescriptions in the U.S."

Meanwhile, as part of Yuflyma's marketing activities, Celltrion Healthcare's U.S. subsidiary plans to provide a patient support program starting from the 10th for patients and healthcare professionals. This program supports copayments and products for patients who are uninsured or underinsured, provided they meet certain conditions.

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