THE World Health Organization (WHO) recommended the two-drug treatment cocktail, casirivimab/imdevimab, for people with COVID-19.
The development comes in the midst of calls by the Doctors Without Borders (MSF) on the US pharmaceutical corporation Regeneron, the manufacturer and patent holder of these drugs, to take immediate actions to ensure the medications are affordable and accessible for everyone who needs them and forego any monopoly on these new treatments.
Given the massive need for COVID-19 medicines around the world, Regeneron should make casirivimab and imdevimab available at a reasonable price, and cease pursuance and enforcement of patents, especially in low- and middle-income countries, including many in which MSF operates. The company should also openly license any proprietary rights attached to these medicines and share their technology and know-how to speed up production and diversify supply by alternative manufacturers around the world.
Casirivimab and imdevimab—as well as tocilizumab and sarilumab, two other COVID-19 treatments that have been recommended by WHO—belong to the class of drugs called monoclonal antibodies (mAbs), which have been on the market for decades for many other diseases, including cancers, with each mAb needing to be tailored to target a specific disease. Existing mAbs are often priced extremely high, and independent developers of ‘biosimilar’ versions of mAbs often face patent barriers and regulatory challenges to introducing their products quickly to increase supply—something that is desperately needed as COVID-19 continues to rage across the globe. This has made production and supply of more affordable mAbs historically very difficult.
It is simply not fair that people living in low- and middle-income countries cannot access new COVID-19 treatments that can decrease the risk of death because of pharmaceutical companies’ monopolies and wishes for high returns,” said Dr Elin Hoffmann Dahl, Infectious Disease Advisor, MSF Access Campaign.
“Casirivimab and imdevimab were only conditionally recommended for COVID-19 today, but Regeneron has already begun applying for patents. Regeneron should instead set an example for all manufacturers of monoclonal antibodies by putting people’s lives before profits, immediately lower the price, stop pursuing monopolies and share the know-how and technology to produce casirivimab and imdevimab with manufacturers in low- and middle-income countries. People everywhere need affordable, sustainable access to lifesaving drugs in this pandemic, as well as in the future.”
Casirivimab/imdevimab has demonstrated in clinical trials a decreased risk of hospitalisation for non-severe COVID-19 patients with high risk of developing severe disease, and a decreased risk of death for COVID-19 patients already in severe condition but who are seronegative (i.e. they have not mounted a natural antibody response of their own). Importantly, this is the very first drug against COVID-19 to be recommended by the WHO for use in non-severe patients to reduce the risk of disease progression for those at highest risk.
As COVID-19 waves continue to surge around the world, demand for this new treatment that can help increase the chance of survival is expected to be high. However, Regeneron has pegged the antiviral cocktail at the high price of US$820 in India, $2,000 in Germany and $2,100 in the US, whilst also having already filed patent applications in at least 11 low and middle-income countries.
Given that Regeneron received significant public funding to develop casirivimab/imdevimab, and that manufacturing costs of mAbs are estimated to be below $100 per gram when produced at large scale, the company should immediately drop the price to reflect the cost of production and engage in technology transfer to other producers. Facing the foreseeable supply constraints of this treatment, governments should make use of all possible legal and policy measures to remove barriers to access to technologies and to accelerate development and introduction of biosimilar alternatives to ensure sustainable supply and access.
MSF and other treatment providers are already facing challenges in accessing the older and repurposed mAb just recommended by WHO, tocilizumab (manufactured by Roche, which is also collaborating with Regeneron for development and distribution of casirivimab/imdevimab outside the US). We are worried that access to the new patent-protected mAbs combination, casirivimab/imdevimab, or any other promising mAbs in the pipeline will be even more challenging.
“In many countries where MSF works in Latin America and Africa, scarce access to hospital beds, insufficient numbers of health care workers to deal with the surge of patients, and lack of medical oxygen makes prevention of hospitalisation vital – an antiviral cocktail like casirivimab/imdevimab could be essential,” said Joan Tubau, former Emergency Field Coordinator for MSF in Brazil.