Pharmasyntez asks Russian Government for permission to produce generic version of remdesivir for COVID-19
pharmafile | November 2, 2020 | News story | Sales and Marketing |
Russian drug firm Pharmasyntez has asked the government for permission to produce a generic version of Gilead’s remdesivir without a patent as a treatment to fight COVID-19 infection.
The company has completed a trial of its generic version, called Remdeform, on 300 patients across 23 Russian hospitals.
The government had previously approved Gilead to request a voluntary licence to produce and distribute the drug in Russia. In October, Pharmasyntez said on its website that it had been granted a marketing authorisation of the drug that would be produced at its factory in Irkutsk.
On their website, the company stated: “If a current patent restriction is removed, Pharmasyntez is ready to start manufacturing Remdeform on a priority basis and to provide its supply, first of all, to health facilities in Russia and, when the domestic demand is met, to other countries in need of it.”
The company has still not been able to produce the drug, however, as it is protected by Gilead’s patent. In its letter, the company asked the Russian Government to activate a compulsory licensing process, which would allow a company to produce patented products in the country without the permission of the patent holder if it is in the interests of national security and defence.
At the end of October, the FDA approved remdesivir, branded as Veklury, for the treatment of novel coronavirus. Following this approval, The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir should consider all the available evidence before awarding marketing authorisation to treat COVID-19. This came after the WHO’s own Solidarity trial found that the drug had “little to no” benefit in reducing COVID-19 mortality.