The Drug Controller General of India (DCGI) has granted Emergency Use Authorization (EUA) to Hetero for launching a biosimilar version of Tocilizumab, a Covid-19 drug for hospitalised adults. The Hyderabad-based company said on Monday the drug would be available in the country by the end of September under the brand name Tocira. Hetero’s Tocilizumab 400mg/20ml is the biosimilar version of Roche’s Actemra/RoActemra drug. Tocilizumab is distributed by Cipla in India under licence from Roche. It has been used for treatment of critical Covid patients to reduce fatalities. The drug was in short supply in the country during the second wave. There is also a global shortage of this drug.
B Partha Saradhi Reddy, chairman of Hetero Group, said the approval was extremely crucial for supply security in India, considering there is a global shortage of Tocilizumab. “This demonstrates our technical capabilities and commitment to bringing important therapeutics relevant to Covid care,” Reddy said. Hetero Biopharma, a Hetero group company, will be manufacturing the drug in Hyderabad. Hetero said the drug would be used for treating Covid-19 in adults who receive systemic corticosteroids and even those who require supplementary oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
Hetero had earlier launched Covd-19 drugs Covifor (generic for Remdesivir) and Favivir (generic for Favipiravir).
Hetero has a licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug Molnupiravir for the treatment of Covid-19. Hetero also has inked a manufacturing partnership with the Russian Direct Investment Fund for manufacturing 100 million doses of the Sputnik V Covid-19 vaccine.
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