Hetero gets DCGI nod for generic of covid drug Tocilizumab
Hetero’s Tocira will be marketed by its associate company Hetero Healthcare in India with the support of its strong distribution network across the country
NEW DELHI : Pharmaceutical firm Hetero on Monday said the Drug Controller General of India (DCGI) has approved Emergency Use Authorization (EUA) for its generic version of Tocilizumab for the treatment of covid-19 in hospitalized adults.
This authorization will enable medical practitioners in India to use the drug for patients who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), the company said in a statement.
Hetero’s Tocira will be marketed by its associate company Hetero Healthcare in India with the support of its strong distribution network across the country. Its biologics arm Hetero Biopharma will be manufacturing the drug at its dedicated biologics facility, based at Jadcherla in Hyderabad, India.
Hetero’s Tocilizumab 400mg/20ml is the biosimilar version of Roche’s Actemra/RoActemra and will be available from September end.
Tocilizumab is part of the Indian government's covid-19 treatment protocol, though as an off-label drug.
“We are pleased with the approval of Hetero’s Tocilizumab (Tocira) in India. This demonstrates our technical capabilities and commitment to bringing important therapeutics relevant to COVID care. This approval is extremely crucial for supply security in India considering a global shortage of Tocilizumab. We will be working closely with the Government to ensure equitable distribution," Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group said.
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