Celltrion said Wednesday that it has applied to the U.S. Food and Drug Administration (FDA) for securing interchangeability between CT-P17 (adalimumab) and its original drug, AbbVie’s Humira, for treating autoimmune diseases.

Celltrion's application for the interchangeability of CT-P17 (Yuflyma in brand name) and Humira is based on the results of a global phase 3 clinical trial.

The trial compared 367 patients with moderate-to-severe plaque psoriasis who received alternating doses of Yuflyma and Humira to those who got Humira alone.

Celltrion believes that recognizing the interchangeability of Yuflyma and Humira through this approval will positively impact Yuflyma's market share in the U.S., allowing pharmacies to substitute Yuflyma for Humira. Yuflyma is a highly concentrated Humira biosimilar that halves the drug dose and eliminates citrate, which can cause pain.

Celltrion is also preparing to get marketing authorization from the European Medicines Agency (EMA) and the U.S. FDA for Yuflyma for various indications, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PsO).

Last September, the FDA approved Yuflyma 80 mg/0.8 ml and 20 mg/0.2 ml formulations, bringing Yuflyma's lineup to three dosage types, including 40 mg/0.4 ml.

Humira is a blockbuster autoimmune disease treatment with sales of approximately $21.37 billion in 2022. In the U.S. alone, the largest market worldwide, Humira generated sales of about $18.69 billion, more than 87 percent of global sales.

"Once the interchangeability between Yuflyma and Humira is secured, we can expect further market share gains in the U.S., the world's largest market, where the climate is favorable for biosimilars," a Celltrion official said.