Russia will produce equivalent of expensive orphan drug

Russian pharmaceutical company Generium will manufacture a bioequivalent of Eculizumab at its facility in the Vladimir Region. The Russian branded product, Elizaria, will be about 25% cheaper than the original drug.

In Western countries, a 24-month Eculizumab therapy costs up to RUR 45 mio ($700,250); in Russia, RUR 26-37 mio ($400,000-$580,000). The original drug, sold under the trade name Soliris, is produced by the American company Alexion. Russia is now the only country that has set up a full-cycle production of an Eculizumab bioequivalent.

Last year alone, Russia spent RUR 8.3 bln (almost $130 mio) to purchase Eculizumab – more than one-third of the total allocations for the treatment of orphan conditions. The drug is used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

The highest selling price of Elizaria, registered by Generium, is RUR 248,000 ($3,860) per pack, which is 25% cheaper than Soliris. Biocad, a leading Russian innovative biotech company, plans to complete the bioequivalence study for its own version of Eculizumab in 2025.

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