The Drug Controller General of India (DCGI) has given its nod to Hetero for Emergency Use Authorization (EUA) of its generic version of Tocilizumab in India for the treatment of Covid-19 in hospitalised adults, the company said.

 The authorisation will enable the medical practitioners to use the generic drug Tocilizumab for the 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), the company statement said.

Hetero’s Tocilizumab 400mg/20ml is the biosimilar version of Roche’s Actemra/RoActemra and will be available from September end.

“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,” said Dr B. Partha Saradhi Reddy, Chairman of Hetero Group.

While Hetero has not announced 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 injection. A Covid-19 patient typically requires about two injections.

“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,” said Dr B. Partha Saradhi Reddy, Chairman of Hetero Group.

Hetero’s TOCIRA (Tocilizumab) 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.