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Hetero gets DCGI emergency use approval for Tocilizumab biosimilar for Covid-19
New Delhi: Drug firm Hetero on Monday said it has received emergency use authorisation from Drug Controller General of India (DCGI) for its biosimilar version of Tocilizumab for treatment of COVID-19 in hospitalised adults.
The company will market the drug under the brand name ''Tocira'', Hetero said in a statement.
This authorisation will enable medical practitioners to use the drug 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, it added.
"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," Hetero Group Chairman, B Partha Saradhi Reddy said.
Tocira will be marketed by Hetero's associate company Hetero Healthcare in India.
Read also: Now Tocilizumab, Amphotericin B tax-free, GST Council reduces tax rate on COVID essentials, Details
Hetero's biologics arm, Hetero Biopharma will manufacture the drug at its dedicated biologics facility, based at Jadcherla in Hyderabad, the statement said.
The company's Tocilizumab 400mg/20ml is the biosimilar version of Roche's Actemra/RoActemra, and will be available from September-end, it added.
Read also: Hetero announces interim clinical results of Molnupiravir in COVID patients in India
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751