Celltrion demonstrates interchangeability of its biosimilar with Humira

Yuflyma [Courtesy of Celltrion Healthcare]

South Korea’s Celltrion announced on Tuesday that it had demonstrated interchangeability between its biosimilar Yuflyma and the original drug Humira to treat autoimmune diseases.

The company conducted a Phase 3 interchangeability clinical trial involving 367 patients with moderate to severe plaque psoriasis to reaffirm whether the efficacy, safety, and other aspects were equivalent when switching from Humira to Yuflyma or continuing solely with Humira.

According to the findings, the initial pharmacokinetic assessment confirmed equivalence with Humira, and the study noted similar results concerning efficacy and safety, the company said.

Based on these results, Celltrion plans to pursue the process for interchangeability approval from the U.S. Food and Drug Administration (FDA) to establish Yuflyma as a biosimilar capable of being substituted for Humira. Once a product receives approval for interchangeability, it can be prescribed by pharmacists without direct intervention from physicians.

Celltrion launched Yuflyma in the U.S. in July and received FDA approval for two different doses in September.

Humira, developed by American pharmaceutical company AbbVie, is a medication for autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis, and psoriasis. It generated sales of $21.2 billion in the U.S. alone last year and is considered the world’s highest-selling non-Covid prescription drug.