Drugmaker Hetero’s generic version of Tocilizumab has recieved Emergency Use Authorisation (EUA) from the Drugs Controller General of India (DCGI).
A biosimilar version of Roche’s Actemra/RoActemra, the product (Tocilizumab 400mg/20ml) is to marketed under the Tocira brand name. It will be available by September end, Hetero said in a release on Monday.
The EUA will enable medical practitioners to use the generic drug for treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), it said.
Hetero Group chairman B.Partha Saradhi Reddy said the approval demonstrates our “technical capabilities and commitment to bring important therapeutics relevant to COVID-19 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.”
Hetero Biopharma will be manufacturing the drug at its facility near Hyderabad and Hetero Healthcare will be marketing the drug.
