DCGI grants EUA to Hetero’s Biosimilar Version of Tocilizumab

This demonstrates our technical capabilities and commitment to bringing important therapeutics relevant to C-19 care

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

India, Hyderabad: Hetero announced today that the Drug Controller General of India (DCGI) has issued for restricted use, Emergency Use Authorization (EUA) for the generic version of Tocilizumab in India.

This authorization will enable the medical practitioners to use the generic drug Tocilizumab for the treatment of C-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group said: “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 C-19 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.”

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, India.

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

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