Moscow-based Amédart has received approval from the Health Ministry to conduct bioequivalence trials of its copy of Betmiga (mirabegron), a drug made by Japan’s Astellas Pharma for overactive bladder. No other products with this active ingredient are currently available on the Russian market. The trial will compare the rate and extent of absorption, as well as safety and tolerability profiles, between the originator and the generic.
According to the state drug registry, the regulator’s permission is valid until the end of 2026. The trial will involve 70 healthy volunteers and will study the drug in 25 mg prolonged-release tablets. The study will be conducted at the Semashko Clinical Hospital in the Yaroslavl region.
Amédart is actively building a portfolio of import-substituting drugs. Earlier it emerged that the company plans to launch a domestic copy of Trikafta in 2027 – the expensive Vertex drug for cystic fibrosis. Currently, only one Trikafta generic is sold in Russia – Trilexa, made by Argentina’s Tuteur. Trilexa is supplied to the country by the Medical Research Company (MIC), which used a compulsory licence and has become embroiled in prolonged patent disputes that remain unresolved.