Biosimilar for Autoimmune Disease Treatment Introduced in the US
Celltrion has newly introduced the biosimilar for autoimmune disease treatment, 'Yuflyma (generic name Adalimumab)' in the 80mg/0.8ml dosage form to the United States.
This Yuflyma 80mg is a high-concentration (100mg/ml) formulation, identical to the 40mg/ml version that began sales in the U.S. last year, and has been launched in two product types: an auto-injector (AI) and a prefilled syringe-S (PFS-S). The price was set the same as the 40mg dose, reflecting the demand of various stakeholders including patients and physicians. Additionally, a 20mg dosage form for pediatric patients is planned to be released within the first quarter. Celltrion plans to pursue sales synergy through customized marketing strategies that reflect the distinct characteristics of each dosage form, as the usage methods differ by dose.
The newly launched Yuflyma 80mg is expected to be primarily used for patients who are newly diagnosed with autoimmune diseases and receiving their first prescription. Since the dosing frequency can be reduced, treatment convenience will be significantly improved for first-time patients who otherwise need to receive the 40mg dose two or more times, patients who need to increase their dose due to reduced treatment efficacy, and patients suffering from injection phobia, thereby enhancing product preference.
Moreover, Yuflyma 80mg, like the 40mg version, removes citrate and allergy-inducing substances that can cause pain to patients, and maintains stability at room temperature (25 degrees Celsius) for 31 days, demonstrating strong product competitiveness. Considering that over 80% of patients treated with the original U.S. product 'Humira' use a high-concentration formulation with citrate removed, the launch of this 80mg dosage form is expected to greatly contribute to increasing preference for Yuflyma.
Celltrion is also in the process of applying for a switching approval to secure interchangeability with Humira to accelerate Yuflyma’s market entry. Once interchangeability status is obtained, even if physicians prescribe Humira, pharmacies will be able to dispense Yuflyma, which has been recognized for equivalent efficacy and safety, enabling more aggressive marketing efforts.
In addition, the patient support program 'Celltrion Connect' is underway. This program supports prior authorization and copay assistance for patients, providing Yuflyma to insured patients who meet the criteria, uninsured patients, and those with insufficient insurance coverage. Celltrion explained that through these marketing activities, awareness and preference for Yuflyma in the U.S. will increase, leading to actual prescription expansion.
Thomas Nussbikel, Chief Commercial Officer (CCO) of Celltrion USA, stated, “Yuflyma has demonstrated the same therapeutic efficacy, safety, pharmacokinetics, and immunogenicity as the original, and with the addition of the 80mg dosage form, we are able to offer physicians and patients more flexible options and convenient self-administration opportunities. Based on strengthening product competitiveness through dosage diversification, we will actively continue marketing activities to ensure that more patients can benefit from Yuflyma’s therapeutic advantages.”
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