WHO prequalifies first monoclonal antibody – tocilizumab – to treat COVID-19
Aiming to increase access to recommended treatments for COVID-19, WHO today added tocilizumab, a monoclonal antibody, to its list of prequalified treatments for COVID-19. 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 manufactured by the originator company, Roche, but the listings should pave the way for more companies coming forward to seek WHO prequalification, thereby increasing the number of quality-assured products and creating competition leading to potentially lower prices. The prequalification of these products will also facilitate low- and middle-income countries’ authorization of them 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 has been authorized mostly for the treatment of arthritis in about 120 countries worldwide.
Tocilizumab given intravenously has been shown in clinical studies to reduce death in certain patients with COVID-19 who are severely ill, are rapidly deteriorating and have increasing oxygen needs, and who have a significant inflammatory response. In the largest clinical trial (RECOVERY), tocilizumab also reduced patients’ time in hospital.
WHO recommends tocilizumab only for patients diagnosed with severe or critical COVID-19. It should be administered by a healthcare worker in a monitored clinical setting along 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 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. Originator company prices paid in lower-income markets are high – reportedly around USD 500-600 per single dose. With demand surging, and more manufacturers entering the market, prices could come down.
WHO and partners are currently discussing lower prices and improved access in low- and middle-income countries with the producer, Roche.
WHO Prequalification was born of the need to ensure a supply of quality-assured health products in low- and middle-income countries. It does this by assessing 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 for the United Nations and other large procurers of health commodities. For example, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance, only purchase health commodities prequalified by WHO. Many countries use the list of WHO prequalified products for their own bulk purchasing of medicines, vaccines, diagnostics and other critical products.
For the complete product list please:
|WHO Reference Number||International nonproprietary name (INN)||Therapeutic Area||Applicant||Dosage form & strength||Date of prequalification|
|BT-CV001 (a)||Tocilizumab||COVID-19||Roche Registration GmbH, Emil-Barell-Strasse, Grenzach-Wyhlen, 79639, Germany||Concentrate for solution for infusion 20 mg/mL (Each vial contains 80 mg of tocilizumab in 4 mL)||10 Feb 2022|
|BT-CV002 (a)||Tocilizumab||COVID-19||Roche Registration GmbH, Emil-Barell-Strasse, Grenzach-Wyhlen, 79639, Germany||Concentrate for solution for infusion 20 mg/mL (Each vial contains 200 mg of tocilizumab in 10 mL)||10 Feb 2022|
|BT-CV003 (a)||Tocilizumab||COVID-19||Roche Registration GmbH, Emil-Barell-Strasse, Grenzach-Wyhlen, 79639, Germany||Concentrate for solution for infusion 20mg/ml (Each vial contains 400 mg of tocilizumab in 20 mL)||10 Feb 2022|
|CV002 (a)(suspended)||Remdesivir||COVID-19||Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland||Powder for solution for injection 100mg||15 Oct 2020|
|CV004||Dexamethasone (sodium phosphate)||COVID-19||Farmak JSC, 63 Kyrylivska St., Kyiv, 04080, Ukraine||Solution for injection 4mg/ml||05 Nov 2020|
|CV005 (a)||Dexamethasone (sodium phosphate)||COVID-19||Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, Nicosia, 1065, Cyprus||Solution for injection 3.3mg/ml (1ml)||17 Dec 2021|
|CV006 (a)||Dexamethasone (sodium phosphate)||COVID-19||Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece||Solution for injection 4mg/ml (2ml)||29 Sep 2021|