Promomed has received approval to conduct a bioequivalence trial of the antiviral drug baloxavir marboxil – the active ingredient in Xofluza, originally developed by Japan’s Shionogi and Switzerland’s Roche. This is the first time a Russian manufacturer has completed the full development cycle for this compound as part of import‑substitution efforts, the company told GxP News. According to the state medicines registry, no generics of this foreign drug are currently available in Russia.
The trial will involve 24 healthy volunteers and will be conducted at the St Petersburg‑based Research Centre Eco‑Safety. Promomed plans to compare the pharmacokinetic parameters of its drug with the reference product. The study is expected to be completed by March 2027, after which a registration decision may follow if bioequivalence is confirmed and legal conditions are met.
Baloxavir marboxil is a modern antiviral with a novel mechanism of action. Unlike neuraminidase inhibitors, which act at later stages, it blocks viral replication early on by inhibiting the cap‑dependent endonuclease enzyme – and the course consists of a single dose. The drug is effective against oseltamivir‑resistant strains and avian influenza.
Roche’s original drug was first approved by the FDA in 2018 for treating influenza. The US regulator later expanded its indications to include post‑exposure prophylaxis. It became available in Russia in March 2021.
According to consultancy Dataintelo, global sales of baloxavir marboxil reached $1.8 billion in 2025, with about $65 million sold in the United States. In 2026, Roche signed an agreement with the Medicines Patent Pool to allow generic production for 129 developing countries. Until this year, baloxavir marboxil had no approved generics with this active ingredient. In June, the FDA approved the first tablet‑form generic of the flu drug from Norwich Pharmaceuticals.
