A biosimilar version of Roche’s Actemra/RoActemra, the product will be available by the end of the month.
Drugmaker Hetero’s generic version of Tocilizumab has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI).
A biosimilar version of Roche’s Actemra/RoActemra, the product (Tocilizumab 400mg/20ml) is to be marketed under the Tocira brand name. It will be available by the end of September, Hetero said in a release on Monday.
The EUA will enable medical practitioners to use the generic drug to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane Oxygenation (ECMO) is required.
Hetero Group Chairman B. Partha Saradhi Reddy said that the approval demonstrates our “technological capabilities and commitment to bring critical medical science relevant to COVID-19 care. This is critical for supply security in India given the global shortage of tocilizumab.” Approval is extremely important. We will work closely with the government to ensure equitable distribution.”
Hetero Biopharma will manufacture the drug at its facility near Hyderabad and Hetero Healthcare will market the drug.
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