INDIA – Hetero, an Indian drug developer, has received emergency use approval from the country’s health authorities to make a generic version of Roche Holding AG’s COVID-19 drug.

Hetero expects to make the treatment, tocilizumab, available in India by the end of the month under the brand name Tocira.

Tocilizumab has been facing a global shortage as the highly contagious COVID-19 Delta variant drives up cases in several countries.

COVID-19 cases in India have declined from levels hit during the second wave in April and May, although health experts believe that the country should brace for a third wave by October.

Roche’s blockbuster arthritis drug, tocilizumab, cuts the risk of death among patients hospitalized with severe COVID-19 along with shortening the recovery time and reducing the need for mechanical ventilation.

Tocilizumab, sold under the brand name Actemra, is an intravenous anti-inflammatory monoclonal antibody used to treat rheumatoid arthritis. It was added to the ‘RECOVERY’ trial in April 2020 for patients with COVID-19 who required oxygen and had evidence of inflammation.

In June last year, the RECOVERY trial found that the cheap and widely available steroid dexamethasone reduced death rates by around a third among the most severely ill COVID-19 patients. That drug has since rapidly become part of standard-of-care recommended for severe patients.

Actemra, along with Sanofi’s similar drug Kevzara, was authorized by Britain’s NHS in early January for COVID-19 patients in intensive care units after preliminary data from a smaller study called REMAP-CAP indicated it could reduce hospital stays by about 10 days.

During 2020, Actemra rose to become Roche’s fifth-best-selling drug, at more than US$3 billion, with nearly US$600 million from COVID-19 treatment.

Tocira will be made by Hetero’s unit at its Hyderabad facility. Hetero, which makes COVID-19 treatments like remdesivir and favipiravir, had also sought emergency approval for Merck’s COVID-19 drug molnupiravir in July.

Molnupiravir is an antiviral drug being developed by Merck & Co and Ridgeback Biotherapeutics for the treatment of non-hospitalized COVID-19 patients.

Merck tapped several Indian generic drug makers between March and April, including Cipla and Dr Reddy’s Laboratories, to expand the drug’s production and conduct trials, hastening its availability in India to address a second wave of infections.

Coronavirus cases in India have declined from a devastating peak in April and May. However, health experts have said the country should brace for a third wave by October.

Molnupiravir is currently being tested in a global late-stage study by Merck and partner Ridgeback, with the trial data expected in the fall of 2021.

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