Russia’s FAS Approves Price for Domestic Generic Version of Erleada

Russia’s FAS Approves Price for Domestic Generic Version of Erleada
Photo: medpagetoday.com 06.06.2025 208

The drug developed by Promomed will be priced 40% lower than the original medication from Johnson & Johnson.

The Federal Antimonopoly Service (FAS) of Russia has approved the price of an anticancer hormone drug — a domestic generic with the INN apalutamide, according to the FAS press service.

The drug, marketed as Apalutamid-Promomed, is produced by Russian pharmaceutical company Promomed. It contains the active ingredient apalutamide and was officially registered in March 2025, according to Russia’s State Register of Medicines. The medication is used to treat prostate cancer in adult men over 18. The original branded version, Erleada, is manufactured by Johnson & Johnson.

The FAS agreed on a price that is 40% lower than the cost of the foreign drug. The agency approved a price of 659 rubles (approximately $7.30) per 60 mg tablet of the generic drug, compared to 1,176 rubles (approximately $13) for the same dosage of Erleada.

"The approval of the price for the first domestic generic under the international nonproprietary name apalutamide will improve access and expand treatment options for patients following the expiration of the original drug’s patent," the agency stated. "It is expected to be made available in medical institutions under the state guarantee program for free healthcare services."

This marks the latest move by Russian regulators to promote domestic alternatives to high-cost imported medications. Earlier, the FAS approved the price for Necteliza, the first locally produced generic version of tenecteplase, developed by Russian biotech company Generium, at 18% below the price of the original.

Source: Pharmvestnik

pharmaceutical markets  Russia 

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