New Delhi: Hyderabad-based drug maker Hetero has submitted an application to start clinical trials and manufacture tocilizumab, a key drug being used in treatment of Covid patients in India, ThePrint learnt.
While India is struggling with a devastating surge in Covid cases, it is also facing a shortage of tocilizumab, currently being used to treat critically ill Covid patients.
Last week, the company submitted the application to conduct clinical trials to the country’s apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), which functions under the Ministry of Health and Family Welfare.
“We have received the application of Hetero to start clinical trials and production of the drug in India,” said a senior government official from the Ministry of Health, who did not wish to be named.
Confirming this, a spokesperson of Hetero told ThePrint: “It is true that we have asked for the approval of the clinical trial and manufacturing of the drug, later.”
The company, however, refused to comment on the possible arrangement with the originator of the product, Swiss pharmaceutical company Roche, which is currently exporting the drug to India, supplying through Mumbai-based Cipla.
ThePrint reached Roche Tuesday via email for a comment, and a reply is awaited. This report will be updated when a response is received.
Hetero Labs also manufactures remdesivir and favipiravir, other drugs being used in Covid treatment.
No clarity on tocilizumab patent status
The Hetero biosimilar is unlikely to be infringing patent.
According to patent experts, the primary patent on the drug expired in 2017. Moreover, it is impossible to manufacture identical biological drugs and hence, only biosimilars can be manufactured.
“In the case of Hetero, the company will manufacture biosimilar and not a biological product. In any event, the patent granted is only on a liquid formulation. Moreover, the primary patent is on the drug expired in 2017,” said senior advocate Anand Grover, who specialises in drug patents.
The industry officials also cited Bolar provisions, which can be used as a defence for patent infringement under which patented products can be manufactured but only for research and development purposes. It allows obtaining regulatory approvals while the patent is valid.
Using the same provision, last year, Indian drugmakers had begun developing remdesivir while they were expecting US-based drug maker Gilead Sciences to extend licences.
“However, these drugs cannot be sold commercially under the Bolar provision. It is Hetero’s responsibility to look for arrangements before selling the drug commercially if the drug is protected,” said an industry official.
Why is tocilizumab used in Covid?
Tocilizumab is a humanised monoclonal antibody that is actually used in the treatment of rheumatoid arthritis. Sold under the brand name Actemra or RoActemra, the drug was approved by the US Food and Drug Administration (FDA) in 2010.
According to the findings of the Randomised Evaluation of COVID-19 Therapy or RECOVERY trial in the UK, the drug reduces the risk of deaths among hospitalised Covid-19 patients, the time spent in hospitals, and the chances of requiring ventilator support.
(Edited by Sanghamitra Mazumdar)