 "Hetero")
Hyderabad based Hetero has got the approval from India’s drug regulator to launch a generic or biosimilar version of Roche’s drug tocilizumab, a drug used widely in moderate to severe Covid-19 patients.
While Hetero has not announced the prices of their drug yet, but once they launch, the prices of the generic version are expected to be relatively cheaper than Roche’s brand Actemra which sells for Rs 40,600 for a single dose. Each patient needs at least two doses.
Hetero said they got a restricted Emergency Use Authorization (EUA) from the Drug Controller of India (DCGI) to launch biosimilar version of Tocilizumab.
The drug is expected to be launched this month under the brand Tocira. Actemra is imported and distributed by Cipla at the moment under a license from Roche.
Industry sources indicated that Cipla may now review the pricing of Actemra.
Tocilizumab is given to hospitalized adult Covid19 patients, who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The EUA will enable doctors to substitute the generic Tocilizumab for the treatment of COVID-19.
Tocira will be marketed by Hetero’s associate company Hetero Healthcare in India while Hetero’s biologics arm Hetero Biopharma will manufacture the drug at its dedicated biologics facility at Jadcherla in Hyderabad.
“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.
