DCGI approves Hetero’s Tocilizumab for emergency use against COVID

Hyderabad-based Hetero announced on Monday it has received Emergency Use Authorisation (EUA) from the Drugs Controller General of India (DCGI) to use its generic version of anti-arthritis drug, Tocilizumab, for treatment of adults hospitalised due to the coronavirus disease (Covid-19), according to news agency ANI. The World Health Organization (WHO), in July, recommended that the drug can be used for critically ill Covid-19 patients.

In a statement, Dr P Sarathi Reddy, chairman, Hetero Group, said that the approval was “extremely crucial” to ensure supply security in India due to a global shortage of Tocilizumab. “We are pleased with the approval of Hetero’s Toilizumab. This demonstrates our technical capabilities and commitment towards bringing important therapeutics relevant to Covid-19 care. We will work closely with the government to ensure equitable distribution,” Dr Reddy noted.

The emergency use approval for TOCIRA, the pharmaceutical firm’s version of Tocilizumab, will ensure that medical practitioners can use it to treat adult Covid-19 patients, who are hospitalised, and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (EMO), the company said.

TOCIRA will be marketed by Hetero Healthcare, an associate company under the Hetero Group, with support from distribution networks from across the country. Its manufacturing, meanwhile, will be the responsibility of the group’s biologics arm, Hetero Biopharma, which will be done at its dedicated biologics facility located at Jadcherla in Hyderabad.

The 400 mg drug, which will be available from the end of this month, is a biosimilar version of Roche’s Actemra/RoActemra.

Hetero is among several Hyderabad-based companies which are involved in India’s fight against the contagious disease, Bharat Biotech International Limited and Dr Reddy’s Labs being the other two. It is engaged in research and development, manufacturing and marketing of chemical and biologic medicines. It is a among the largest producers globally of active pharmaceutical ingredients (API). Hindustan Times