Drugmaker Mylan NV said on Monday it would launch its generic version of Gilead Sciences Inc's COVID-19 treatment remdesivir in India this month at 4,800 rupees ($64.31) per 100 mg vial, as infections surge in the world's third worst-hit country.
The Drug Controller General of India (DCGI) approved Mylan's remdesivir version, to be called Desrem, for the treatment of suspected or laboratory confirmed severe incidences of COVID-19 in adults and children, the company said in a statement.
Mylan's version comes after two Indian drugmakers, Cipla Ltd and privately-held Hetero Labs Ltd, launched their generic versions of the drug.
Cipla will price its version, Cipremi, at less than 5,000 rupees, while Hetero has priced its version, Covifor, at 5,400 rupees.
Gilead has priced remdesivir at $2,340 per patient for wealthier nations. It has agreed to send nearly all of its supply of the drug to the United States over the next three months, stirring concerns about availability elsewhere.
Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial. On Friday, it got conditional approval from the European Commission for use in severe COVID-19 patients.
Mylan said it was working toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so.
The company will manufacture remdesivir in India at its injectables facilities, which also make products for the US and have been inspected by the United States Food and Drug Administration (USFDA) for compliance with good manufacturing practices, it added.
"The approval by DCGI in India represents the first for Mylan in these 127 markets," Mylan said.
The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, it added.
"Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world," Mylan President Rajiv Malik said.
"Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic," Malik said.
Gilead has signed licensing agreements with India's Dr.Reddy's Laboratories Ltd, Jubilant Life Sciences Ltd, Syngene International Ltd and Zydus Cadila, listed as Cadila Healthcare Ltd, to make and sell remdesivir.
Cases of the novel coronavirus in India stood at 697,413 on Monday, health ministry data showed, while the death toll stood at nearly 20,000.
(With inputs from PTI)