Binnopharm Group has received a registration certificate for Eltrombopag-Alium. The tablets are a generic version Revolade (eltrombopag), a thrombopoietin-like drug developed by the British pharmaceutical giant GlaxoSmithKline (GSK).
The company told GxP News that the product is a thrombopoietin receptor agonist intended to treat patients with thrombocytopenia. Commercial production of Eltrombopag-Alium is set to begin this month at the Alium plant in the Moscow region town of Obninsk.
The patent protection for the original brand-name drug expired earlier this year. According to the Russian State Register of Medicines, the market currently features nine generic versions of Revolade from eight domestic manufacturers—Izvarino Pharma, Velfarm-M, PSK Pharma, Amedart, R-Pharm, Geropharm, Pharmasyntez, and Life Sciences OHPhC—as well as one foreign company, India’s Hetero Labs.
Binnopharm Group emphasized that “treating orphan diseases involves significant financial costs for the state budget, which makes the import substitution of such drugs a particularly high priority.”
Thrombocytopenia is characterized by a low platelet count in the blood, which impairs its ability to clot. The condition can lead to severe internal bleeding, including hemorrhagic stroke. The most common chronic form is immune thrombocytopenia, which has an incidence rate of approximately two cases per 100,000 adults per year.
