Hetero, on September 6, said it had received restricted Emergency Use Authorization (EUA) from the Drug Controller of India (DCGI) to launch biosimilar version of Tocilizumab.
Hetero announced that the drug would be available from September end under brand name Tocira. Hetero’s Tocira 400mg/20ml is the biosimilar version of Roche’s Actemra/RoActemra. The drug is distributed by Cipla in India under license from Roche.
While Hetero did not announce the price of the drug, the biosimilar version was expected to be cheaper than the branded Tocilizumab which is priced at Rs 40,600 per single injection. A COVID-19 patient would typically require about two injections.
The EUA will enable doctors to use the generic Tocilizumab for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Hetero’s said Tocira will be marketed by its associate company ‘Hetero Healthcare’ in India with the support of its strong distribution network across the country.
Hetero’s biologics arm ‘Hetero Biopharma’ will be manufacturing the drug at its dedicated biologics facility, based at Jadcherla in Hyderabad, India.
“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," said B. Partha Saradhi Reddy, Chairman, Hetero Group.
"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,” Reddy added.
Hetero was also the first company to develop generic version of COVID-19 antiviral drug Remdesivir.
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