Russian Government-Controlled Company Makes Unauthorized Generic Remdesivir

St. Petersburg, Russia-based Pharmsynthez has reportedly begun manufacturing a generic version of Gilead Sciences’ COVID-19 antiviral treatment Veklury (remdesivir) without the U.S. company’s permission.

Pharmsynthez, which is linked to the Russian government, sought a compulsory license last year allowing it to manufacture the drug, claiming it had not heard back from Gilead after writing to discuss a patent licensing agreement last July (DID, Nov. 3, 2020).

The RUSNANO Group, a Russian government entity that implements state policy for the development of the country’s nanotechnology industry, describes Pharmsynthez as part of its portfolio. The government has not disclosed how much it plans to compensate Gilead for the use of its patent.

“We are disappointed by the Russian government’s decision to issue a compulsory license for Veklury,” a Gilead spokesperson told FDAnews. “We believe this action is unnecessary and counterproductive, as Gilead has priced Veklury in a way that yields cost savings for governments around the world.”

Gilead is already partnered with another Russian company, JSC Pharmstandard, that “already lays the local groundwork to pursue the market launch and distribution of Veklury in Russia,” the company said, adding that it currently has “a sufficient supply of Veklury to provide to patients in Russia.”

In the U.S., some patent experts have also raised the possibility of the U.S. government invoking a clause of patent law designed for wartime to have a generic drug company manufacture remdesivir, while compensating Gilead (DID, Feb. 2). — Martin Berman-Gorvine