New Delhi Roche Holding AG’s generic version of tocilizumab, an immunosuppressant used to treat severe cases of COVID-19, has been approved for emergency-use in India, drugmaker Hetero said on Monday.
The Hyderabad-based Hetero’s version will be available from the end of September. “Given the global shortage of tocilizumab, this approval is important for supply security in India. We will work closely with the government to ensure equitable distribution.”
The drug was in short supply due to infections and hospitalizations during the second wave of the pandemic, with patients paying multiples of the price of the drug to buy it. Cipla is the sole distributor of Roche’s Tocilizumab in India. Hetero said authorization by the Drugs Controller General of India (DCGI) would allow doctors to use it to treat COVID in hospitalized adults who are receiving systemic corticosteroids and supplemental oxygen, mechanical ventilation, or extracorporeal membranes. Oxygenation is required.
Tocilizumab is used along with steroids to quell the overactive immune response in severe covid patients. It was originally developed to treat inflammatory diseases such as rheumatoid arthritis. Tocilizumab is also part of India’s COVID treatment protocol, albeit as an off-label drug. Hetero’s Tocira will be marketed in India by its subsidiary ‘Hetero Healthcare’.
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