Russia Begins Bioequivalence Trials of Generic Gilteritinib for FLT3-Mutated Acute Myeloid Leukaemia
核心洞察
Russia's Health Ministry has authorized domestic drugmaker Ammedart (搜索) to conduct bioequivalence trials of a generic version of Astellas' Xospata (gilteritinib) for acute myeloid leukaemia (搜索).
The trial will enroll 100 healthy volunteers at the Yaroslavl Regional Clinical Narcological Hospital, with authorization valid until the end of 2026.
Xospata is indicated as monotherapy for adults with relapsed AML carrying an FLT3 (搜索) mutation and holds orphan status, ranking among Russia's most expensive state-procured drugs.
Russia's Health Ministry has granted Moscow-based drugmaker Ammedart (搜索) permission to conduct bioequivalence trials of its generic for acute myeloid leukaemia (搜索) (AML), a copy of the original Japanese Astellas Pharma product Xospata (gilteritinib). According to the state medicines registry, only the original drug from this manufacturer is currently registered in Russia, underscoring the significance of a potential domestic generic alternative.
The trials will be conducted at the Yaroslavl Regional Clinical Narcological Hospital, involving 100 healthy volunteers. The authorization is valid until the end of 2026.
Indication and Clinical Positioning
Xospata is indicated as monotherapy in adults with relapsed acute myeloid leukaemia (搜索) carrying an FLT3 (搜索) mutation. The drug has orphan status and is included in clinical guidelines. In 2024, the Circle of Good foundation expanded its procurement list to include Astellas' gilteritinib, reflecting the drug's recognized role in treating this patient population.
Market Context and Cost Burden
According to analytics firm Cursor, Xospata ranked among the most expensive drugs on the Russian state market. Between January and August 2025 alone, 326 packs of the drug were procured through government purchases for a total of 631.3 million roubles. The weighted average cost per pack was 1.9 million roubles (approximately $23,000), highlighting the substantial financial burden associated with the originator therapy.
Ammedart's Expanding Clinical Trial Portfolio
According to Headway Company analysts, Ammedart (搜索) has topped the Russian ranking of clinical trial organizers, having initiated 37 new projects. The Moscow-based manufacturer significantly outpaced other major market players, including Velfarm-M (25 projects) and Farmstandard (15 studies). This latest authorization adds to Ammedart's growing pipeline of generic oncology and specialty drug development programs.