The Russian Ministry of Health has granted “R-Pharm” permission to conduct clinical trials (CT) for generics of two drugs: the oncology drug Zenlistik (abemaciclib) from Eli Lilly and the hepatitis C treatment Mavyret (glecaprevir/pibrentasvir) from AbbVie. Both medications are protected by Eurasian patents in Russia until 2034 and 2033, respectively. The trials will take place at the “Research Lab” organization.

“R-Pharm” plans to conduct a crossover study of the pharmacokinetics and bioequivalence of its generic DT-ABM (abemaciclib) compared to Eli Lilly’s original drug. Seventy-five healthy volunteers will participate in the trial, which is scheduled for completion by December 31, 2027.

In March 2023, Eli Lilly transferred the rights for the import and sale of its products in Russia, including Zenlistik, to Swiss company Swixx BioPharma. The drug is protected by a Eurasian patent until 2034. Previously registered under the trade name Verzenio, the medication was re-registered as Zenlistik by Swixx BioPharma in September 2023.

In early November 2024, the Ministry of Health also authorized “R-Pharm” to conduct clinical trials of a generic version of Mavyret (glecaprevir/pibrentasvir). According to the State Register of Medicines (GRLS), “R-Pharm” aims to establish the bioequivalence of its analog DT-GLPI to Mavyret when administered orally as a single dose to healthy volunteers after a high-calorie breakfast. This trial will also conclude by the end of 2027, involving 165 participants.

Mavyret is protected by a Eurasian patent until 2033. In June 2023, the drug was included by the Russian government in the List of Vital and Essential Drugs (VED). It is currently the only medication in Russia approved for treating chronic viral hepatitis C in children aged 3 to 12 years.

Source: Vademecum, November 2, 2024.