Hetero’s Biosimilar Version of Tocilizumab (Tocira) receives Emergency Use Authorization (EUA) from DCGI for the treatment of Covid-19 in hospitalized adults

~ Hetero to market the anti-Covid drug under the brand name ‘Tocira’

India, Hyderabad; 06th September, 2021: Hetero, a globally renowned vertically integrated pharmaceutical organization 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 Covid-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 Tociluzumab (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 Tociluzumab. 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.

Hetero entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of COVID-19. Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.

Hetero completed a phase 3 clinical trial (approved by CDSCO) in about 1218 COVID-19 patients, the data of which was approved by subject expert committee (SEC) and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing (M&M).