Celltrion revealed on Dec. 26 that its biosimilar for autoimmune diseases, Yuflyma (CT-P17), has demonstrated equivalence and safety compared to the original drug, Humira.
Developed by the American company AbbVie, Humira recorded sales of approximately US$21 brillion last year, making it the world’s largest blockbuster drug.
Celltrion reported that the global phase 3 clinical trials have proven the interchangeability between Yuflyma and Humira. The trials evaluated pharmacokinetics, efficacy, and safety, with similar results in secondary endpoints.
Based on these clinical results, Celltrion plans to enter the process for obtaining interchangeability approval from the U.S. Food and Drug Administration (FDA). Once approved, it would allow patients to switch from the original drug to Yuflyma with the same efficacy and safety, enabling pharmacies to prescribe Yuflyma instead of the original drug without physician intervention.
Following the clinical trials, Celltrion is seeking approval from the European Medicines Agency and the FDA to market Yuflyma for all indications held by Humira, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis.