Johannesburg – Doctors Without Borders (MSF) says Swiss pharmaceutical corporation Roche – the world’s sole producer tocilizumab – should urgently share know-how and technology with drug-makers in low and middle-income countries to scale up production and accessibility.
The World Health Organisation on July 6 recommended tocilizumab for people with severe COVID-19, prompting MSF to call on the Swiss pharmaceutical corporation to make the drug affordable and accessible.
Tocilizumab belongs to a class of drugs called monoclonal antibodies (mAbs), which are used in the treatment of diseases as cancers. However, most mAbs are expensive.
“Roche must end its monopoly and urgently share the know-how, master cell lines and technology needed to produce this drug with other manufacturers across the world to ensure supply and improved access. Medical practitioners in many countries in Africa and Latin America, who are grappling with newer and more transmissible variants of coronavirus, are right now struggling to keep their patients alive,” said Julien Potet, policy advisor with MSF’s Access Campaign.
Potet added, “Roche must stop following a business-as-usual approach … Too many lives are at stake.”
Tocilizumab has been on the market since 2009. According to MSF, Roche has kept the price of the drug high: at US$410 in Australia, US$646 in India, and US$3,625 in the United States for a 600mg dose needed for COVID-19 management.
The cost of manufacturing tocilizumab is estimated at just US$40 per 400mg when when produced on a large-scale.
The main patent on tocilizumab expired in 2017, yet several secondary patents remain.
Several “biosimilar” versions are under development, but none have been approved for use yet, meaning Roche has a virtual monopoly.
Another MSF Access Campaign advisor, Leena Menghaney, said: “In India the second wave in May, Roche’s distributor ran out of the drug and not a single vial was available in the country for critical patients. Over the last few months, we have helplessly witnessed people in South Asia scrambling to get hold of tocilizumab for patients with severe forms of COVID-19.
“Manufacturers based in low and middle-income countries urgently need to register and scale up production to increase the global supply. With more than 3.9 million lives already lost to COVID-19, the world cannot wait any longer for access to treatments that can help in increasing the chances of survival.”
Besides tocilizumab, two new antiviral mAbs – casivirimab and imdevimab – produced as a cocktail by US pharmaceutical corporation Regeneron, have recently demonstrated in clinical trials to decrease the risk of death among hospitalised COVID-19 patients.
Regeneron has pegged the cocktail at US$820 in India, US$2,000 in Germany and US$2,100 in the United States.
Another mAb recommended by WHO this week Sarilumab is under wide patent protection globally.