South Korea’s biopharmaceutical company Celltrion Inc. has taken a significant step forward in the competitive biologics market by applying to the US Food and Drug Administration (FDA) for modified approval of its biosimilar, Yuflyma. This move aims to establish Yuflyma as interchangeable with the original drug, Humira, for the treatment of autoimmune diseases.
Humira, a highly successful drug with global sales reaching $21.2 billion last year, is widely used in the treatment of various autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Notably, a substantial portion of its sales, amounting to $18.6 billion, originated from the US market.
Celltrion’s Yuflyma, developed as a biosimilar to Humira, received sales approval in the US last year. The current application for interchangeability is a strategic move by Celltrion. If granted, it would allow Yuflyma to be substituted for Humira directly at pharmacies, without the need for a separate prescription from healthcare providers. This capability is crucial for gaining a competitive edge in the market.
The pursuit of interchangeability is a common goal among biosimilar developers, as it not only validates the similarity of the biosimilar to the original drug but also greatly enhances market accessibility and competitiveness.
Celltrion has already laid the groundwork for this approval through a Phase 3 clinical trial, which involved 367 patients with moderate to severe plaque psoriasis. The trial successfully demonstrated statistical equivalence between Yuflyma and Humira, bolstering Celltrion’s case for interchangeability.
With the potential recognition of Yuflyma as interchangeable with Humira, Celltrion anticipates a significant boost in its market share within the US. This development could have far-reaching implications in the biologics market, particularly in the realm of autoimmune disease treatments.
