The World Health Organization (WHO) has added tocilizumab, a monoclonal antibody, to its list of prequalified treatments for COVID-19.
The WHO, in a statement posted on its website, said the prequalification of tocilizumab responds to the need to ensure a supply of quality-assured health products in low- and middle-income countries.
It does this by evaluating the quality, safety and efficacy of a wide range of health products to prevent, diagnose and treat priority diseases.
Prequalification is a vital service provided to the UN and other major purchasers of health products.
For example, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance, purchase only WHO-prequalified health products.
Many countries use the WHO Prequalified Products List for their own bulk purchases of medicines, vaccines, diagnostics and other critical commodities.
To date, six COVID-19 treatments have been prequalified by WHO, including the three presentations (three vials, each with a different quantity) of the product prequalified today.
The three prequalified products are made by the original company, Roche, but the listings are expected to pave the way for more companies to apply for WHO prequalification, increasing the number of quality-assured products and creating driving competition. potentially lower prices.
Prequalifying these products will also facilitate their approval by low- and middle-income countries as treatments for COVID.
Tocilizumab is a monoclonal antibody that inhibits the interleukin-6 (IL-6) receptor. Interleukin-6 induces an inflammatory response and is found at elevated levels in critically ill patients with COVID-19.
So far, the product has been approved primarily for the treatment of arthritis in around 120 countries around the world.
Intravenously administered tocilizumab has been shown in clinical studies to reduce mortality in some COVID-19 patients who are critically ill, rapidly deteriorating and have increasing oxygen requirements, and who have a significant inflammatory response.
In the largest clinical trial (RECOVERY), tocilizumab also reduced the time patients were hospitalized.
WHO recommends tocilizumab only for patients diagnosed with severe or critical COVID-19.
It should be administered by a healthcare professional in a supervised clinical setting with the current standard of care for COVID-19, which includes oxygen, corticosteroids, and other medications.
Tocilizumab’s patent has expired for most of its uses, which means there should be no intellectual property barriers for this particular IL-6 blocker.
However, the global availability of product-assured biosimilars is low.
Currently, tocilizumab is expensive and in short supply around the world.
The prices paid by originators in low-income markets are high – around US$500-600 per single dose.
As demand increases and more manufacturers enter the market, prices may come down.
WHO and partners are currently discussing lowering prices and improving access in low- and middle-income countries with producer Roche.