The Russian Ministry of Health has issued a registration certificate to the Russian company R-Pharm for Grozavir (grazoprevir / elbasvir) for the treatment of viral hepatitis C. The full-cycle of drug production will take place at the R-Pharm Novoselki site. The information appeared in the State Register of Medicines. The drug is the first Russian generic of MSD’s Zepatier. However, the active ingredients of the original medicine are protected by a patent in Russia until September 2033. R-Pharm informed GxP News that the registration of Grozavir does not violate the intellectual rights of the originator.
The company explained that R-Pharm had previously supplied the original drug to the Russian market in partnership with MSD. “The registration of Grozavir is a continuation of the Russian company’s mission to expand the availability of medicines intended for key areas of government policy in the field of Russian healthcare,” the press service of the Russian company added.
The drug is in demand by the Russian healthcare system due to its efficacy and safety. From 2023 to 2024, every fourth patient with hepatitis C in the country received medicines with INN grazoprevir / elbasvir. The drug was mainly prescribed to Russians with the most common hepatitis C virus genotype I, detected in about 50% of cases).
In addition, the cost of such treatment is lower in comparison with the so-called pan-genotypic treatment regimens. The registration of the generic drug will increase the availability of hepatitis C virus therapy, as well as ensure budget savings at all levels, including for the federal project “Combating hepatitis C and minimizing the risks of the spread of the disease.”
According to the GRLS, Grozavir will be produced in the form of film-coated 100 mg + 50 mg tablets. The drug is included in the list of vital and essential drugs (VED) and is available subject to prescription. The maximum price for the generic drug has not yet been set, while the original Zepatier costs about 74,000 rubles.
In August 2023, the MSD announced that it would stop supplying Zepatier to Russia after 2024. There were no analogues of the drug in the country at that time, despite the availability of other drugs. According to the rules, companies must report such decisions at least one year before the actual cut of the import.
Vladimir Chulanov, the chief freelance specialist in infectious diseases at the Russian Ministry of Health, said at the time that there were no risks for patients due to the cessation of supplies of Zepatier to Russia. He explained that R-Pharm (a partner of the American manufacturer) has a sufficient stock of Zepatier and plans to supply the drug under all current contracts in volumes sufficient to cover the needs of the Russian healthcare system until 2025.
In March of this year, it became known that another Russian company, Geropharm, appealed to the court for the issuance of a compulsory license for Zepatier. As follows from the GRLS data, the company has already completed clinical trials.
