WHO pre-qualifies the first monoclonal antibody
WHO pre-qualifies the first monoclonal antibody

WHO pre-qualifies the first monoclonal antibody

In order to increase access to recommended treatments for COVID-19, the WHO has today added tocilizumab, a monoclonal antibody, to its list of pre-qualified treatments for COVID-19. To date, six COVID-19 treatments have been pre-qualified by the WHO, including the three presentations (three vials, each with a different amount) of the product that are pre-qualified today.

The three pre-qualified products are manufactured by the original company Roche, but the listings should pave the way for more companies to apply for WHO pre-qualification, thereby increasing the number of quality-assured products and creating competition that could lead to potentially lower prices. The pre-qualification of these products will also facilitate the approval of low- and middle-income countries as COVID treatments.

Tocilizumab is a monoclonal antibody that inhibits the interleukin-6 (IL-6) receptor. Interleukin-6 induces an inflammatory response and is found in high levels in patients critically ill with COVID-19.

So far, the product is mainly approved for the treatment of arthritis in about 120 countries worldwide.

Tocilizumab given intravenously has been shown in clinical trials to reduce mortality in certain patients with COVID-19, who are severely ill, rapidly deteriorating and have increasing oxygen demand, and who have a significant inflammatory response. In the largest clinical trial (RECOVERY), tocilizumab also reduced patients’ time in hospital.

The WHO only recommends tocilizumab for patients diagnosed with severe or critical COVID-19. It should be administered by a healthcare professional in a supervised clinical setting in conjunction with the current standard of care for COVID-19, which includes oxygen, corticosteroids, and other medications.

The patent for tocilizumab has expired for most of its uses, which means that there should be no intellectual property barriers for this particular IL-6 blocker. However, there is low global availability of quality assured biosimilars of the product.

Currently, tocilizumab is expensive and in short supply globally. Prices for original companies paid in lower income markets are high – reportedly around USD 500-600 per share. single dose. With increasing demand and more manufacturers entering the market, prices may fall.

WHO and partners are currently discussing lower prices and improved access in low- and middle-income countries with the manufacturer Roche.

Pre-qualification

WHO pre-qualification is born of the need to ensure a supply of quality-assured health products in low- and middle-income countries. It does so by assessing the quality, safety and efficacy of a wide range of healthcare products for the prevention, diagnosis and treatment of 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, only purchase health products pre-qualified by the WHO. Many countries use the list of WHO pre-qualified products for their own mass procurement of medicines, vaccines, diagnostics and other critical products.

For the complete product list, please see: https://extranet.who.int/pqweb/medicines/prequalified-lists/finished-pharmaceutical-products

For more information, please visit the WHO Pre-Qualification Unit website at https://extranet.who.int/pqweb

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