Experts presented the results of observations of patients taking the first generic version of Tricafta— a cystic fibrosis medication produced by the American biopharmaceutical company Vertex Pharmaceuticals— at a press briefing as part of the nationwide project “Bronchiectasis: Cystic Fibrosis and Beyond,” held in Astrakhan. Trilexa from the Argentine Tuteur S.A.C.I.F.I.A. is a generic triple-acting drug, elexacaftor/tezacaftor/ivacaftor in combination with ivacaftor tablets, which was registered in Russia at the end of 2024.
Specialists from the Moscow Scientific and Clinical Department of Cystic Fibrosis at the Academician N. P. Bochkov Research Centre for Medical Genetics monitored the condition of 151 patients with the disease who took the generic drug for three months. The centre said in a statement that results showed patients’ lung function continued to improve, their body mass index increased, and the therapy was well-tolerated.
“We even see a trend towards rarer manifestations of adverse reactions,” said Elena Kondratyeva, head of the department. She added that an analysis of two groups of 30 patients each – one starting on the generic and another switching from the original drug – showed both groups experienced identical improvements in lung function and nutritional status, alongside a similar reduction in sweat test values. “These data lead to the conclusion that the two drugs, the original and the generic, do not differ from each other in efficacy and safety,” Kondratyeva said.
Experts from Astrakhan also reported positive outcomes of switching to the generic drug. Professor Diana Sergienko of the Astrakhan State Medical University said the clinical condition of patients is characterized by a stable remission of the bronchopulmonary process. “The results indicate the preservation of clinical and functional stability, and a favorable safety profile when changing the drug within the same INN in children with cystic fibrosis,” she stated, noting that children from the age of six are being switched to the generic, while younger patients continue to receive the original drug.
According to the statement, the procedure for switching patients between targeted therapies under the same INN has been defined in new clinical guidelines. This section was added to the guidelines following a letter from the Russian Ministry of Health No. 15-1/И/2-1467 dated January 30, 2025.
