On Monday, Celltrion announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the interchangeability of its autoimmune disease treatment, Yuflyma (adalimumab), with the original drug, Humira.
The U.S. interchangeability designation allows pharmacies to substitute biosimilar drugs for original products when they demonstrate equivalent efficacy and safety. This status enables patients to receive biosimilar drugs at pharmacies without a new prescription, which are considered therapeutically equivalent to the original product.
Celltrion’s application for interchangeability was based on a global clinical trial involving 367 patients with moderate to severe plaque psoriasis.
This approval grants Yuflyma interchangeability status in the U.S., which is expected to boost consumer confidence in its use as an alternative to Humira. This status could significantly impact market share in the U.S., where prescriptions typically use generic names rather than brand names.
Yuflyma, Celltrion’s high-concentration biosimilar of Humira, offers half the injection volume of lower-concentration versions and eliminates citrates, which can cause injection site pain. The company currently supplies three different dosage volumes of this high-concentration product globally.
Celltrion has gained market share in key European countries through targeted bidding strategies. In the U.S., the company is rapidly expanding its distribution channels using a dual pricing strategy, contributing to accelerated global sales growth.
Humira, the reference product for Yuflyma, generated approximately $8.993 billion in sales last year. The U.S., the world’s largest pharmaceutical market, accounted for over 79% of this revenue, about $7.142 billion.
A Celltrion spokesperson stated, “The interchangeability approval for Yuflyma strengthens our competitive position in the rapidly growing U.S. market. We’re committed to improving access to Yuflyma in the world’s largest adalimumab market and expanding our market presence.”