Celltrion announced on October 4 that it has received approval from the U.S. Food and Drug Administration (FDA) for two additional dosage forms of its Humira (adalimumab) biosimilar Yuflyma (development name: CT-P17): 80mg/0.8mL and 20mg/0.2mL (hereafter referred to as 80mg and 20mg).
The addition of these two dosage forms for Yuflyma brings Celltrion's lineup of high-concentration adalimumab products to three dosage forms, including the existing 40 mg/0.4 mL.
With the addition of these two approved high-concentration adalimumab dosage forms, Celltrion will be able to actively contribute to a prescribing environment that meets the needs of patients and providers.
The availability of an 80 mg prescription to reduce dosing for patients who require higher doses based on indication and a 20 mg prescription for pediatric patients who require lower doses will further increase Yuflyma preference and convenience for personalized prescribing.
Yuflyma is characterized by the elimination of citrate, which can cause pain, in a high-concentration formulation that halves the drug dose compared to lower concentrations. The major global markets for adalimumab, including Europe and the US, are already shifting toward higher concentrations.
In the U.S., high-concentration formulations are overwhelmingly prescribed due to their ease of administration. According to U.S. pharmaceutical market research firms Symphony Health and IQVIA, high-concentration formulations accounted for more than 85% of adalimumab sold in the U.S. last year.
Yuflyma's access to three different dosage forms, as well as both auto-injector (AI) and prefilled syringe (PFS) formats, is expected to broaden the range of eligible patients and positively impact sales and share in the US.
Yuflyma's original drug, Humira, is a blockbuster autoimmune disease treatment marketed by Abbvie in the U.S., with sales of approximately $21.237 billion last year. The U.S. market alone, which is considered the largest market, accounted for about $18.69 billion in sales, more than 87% of global sales.
Celltrion plans to expand its market presence in the adalimumab market by securing additional differentiated competitiveness compared to other companies.
