Celltrion announced on Oct. 4 that it had obtained additional approval from the U.S. Food and Drug Administration (FDA) for 80mg/0.8mL and 20mg/0.2mL (hereinafter referred to as 80mg and 20mg) dosages of its Humira (active ingredient: adalimumab) biosimilar, Yuflyma (development code: CT-P17), on Sept. 29 (local time).
With the recent addition of these approvals, Celltrion has now completed a lineup of high-concentration adalimumab products, including its existing 40mg/0.4mL dosage.
The newly approved two high-concentration adalimumab dosages allow for reduced frequency of administration for patients requiring higher doses through an 80 mg prescription. Conversely, pediatric patients who need lower doses can now be prescribed the 20 mg dosage.
Yuflyma stands out as a high-concentration formulation that halves the drug administration amount compared to lower concentrations, and notably removes citrate, which can cause pain.
Major adalimumab markets in Europe and the U.S. have already reorganized around high-concentration formulations. Especially in the U.S., prescriptions for high-concentration formulations, which offer increased convenience for patients, are overwhelmingly dominant. According to market research institutions Symphony Health and IQVIA, more than 85% of adalimumab sold in the U.S. last year were in high-concentration form.
Celltrion is focused on expanding its influence in the adalimumab market. As part of this effort, the company is planning to complete global Phase 3 clinical trials for interchangeability between Yuflyma and Humira by the end of the year, having already secured clinical trial approvals in the U.S. and Europe. Additionally, Celltrion has entered into a contract with U.S. biotech company Lani Therapeutics for the development of an oral form of adalimumab. Upon successful development, the two companies have secured the right to prioritize negotiations on global development and sales rights, intending to improve patient convenience and expand market influence.
Meanwhile, Humira, the original drug of Yuflyma, is a blockbuster autoimmune disease treatment sold by U.S.-based Abbvie. Last year, it recorded sales of approximately US$21.237 billion, with the U.S. market alone accounting for over 87% of global sales, totaling around US$18.619 billion.