The first Ukrainian generic drug against COVID-19, which affects the pathogenesis of the virus, on December 15 successfully completed the clinical phase of bioequivalence studies. In early 2021, it is expected to enter the market under the name “Favipiravir – Microkhim”.
“On December 15, as part of the bioequivalence study procedure, we successfully completed the clinical phase of the study of the drug” Favipiravir – Microkhim “. It was performed on the basis of the therapeutic department of the Clinical Diagnostic Center “Pharmbiotest” – the leader of the domestic market for comprehensive studies of bioequivalence and pharmacokinetics of drugs in Ukraine. This was preceded by a control examination of the drug in the authorized laboratory of the State Expert Center at the Ministry of Health of Ukraine,”– said the General Director of “Microkhim” Igor Pogromsky.
Favipiravir – Microkhim is the first Ukrainian generic of the Japanese antiviral drug Avigan (international non-proprietary name – Favipiravir). In September, Japanese researchers in clinical trials received evidence of the effectiveness of the drug to combat COVID-19. At the same time, Favipiravir is included in the approved Ukrainian protocol for the treatment of diseases caused by coronavirus infection.
Instead, the chief physician of the research institution – KDC “Pharmbiotest” Hryhoriy Tsapko noted that “the next stage of the study is bioanalytics, the results and reports of which the State Expert Center will determine the official registration of the drug in Ukraine. Prior to that, it will be impossible to buy the drug over the counter. For our part, we as a research institution will do our best to complete our work as soon as possible. We currently plan to complete the bioanalytical part in December so that Ukraine can receive its coronavirus medication in January next year. We are aware of our full responsibility to Ukrainians, as the situation with the spread of COVID-19 remains critical with a deteriorating trend.”
Earlier, the manufacturer of the drug – the company “Microkhim” has already stated that after the registration of the drug is ready to agree with the Ministry of Health and implement the procedure of transferring the batch of the drug to medical institutions free of charge.