The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.
WHO’s prequalification of medicines is a service provided by the organization to assess the quality, safety and efficacy of medicinal products. It was started in 2002 in partnership with UNAIDS (Joint United Nations Programme on HIV/AIDS), UNICEF (United Nations Children's Fund) and the UN Population Fund, with support from the World Bank [1].
The first biosimilar to be prequalified by WHO was a trastuzumab biosimilar produced by Samsung Bioepis [2]. Trastuzumab is a monoclonal antibody treatment for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric cancer. On 11 June 2020, WHO prequalified a further trastuzumab biosimilar produced by Mylan Pharmaceuticals.
On 14 July 2020, WHO announced the prequalification of a third trastuzumab biosimilar – Herzuma, which is produced by the South Korean biotechnology company Celltrion Healthcare. Herzuma was launched in the US in March 2020 [3] and has been prequalified by WHO in two doses, 150 mg and 420 mg.
This is the second of Celltrion’s biosimilars to be prequalified by WHO. In May 2020, WHO prequalified Celltrion’s rituximab biosimilar, Truxima [4].
Rituximab is an antibody treatment for autoimmune diseases including rheumatoid arthritis and cancers of the blood. Celltrion’s rituximab was the first biosimilar version to be prequalified by WHO, see Table 1.
| Table 1: WHO prequalified biosimilars as of 21 August 2020
|
| Product
|
Dosage/strength
|
Licensed to
|
Date of prequalification
|
| Rituximab
|
Concentrate for solution for infusion*
|
Celltrion
|
25 May 2020
|
| Trastuzumab
|
Powder for concentrate for solution for infusion, 150 mg and 420 mg
|
Celltrion
|
14 July 2020
|
| Trastuzumab
|
Powder for concentrate for solution for infusion, 150 mg
|
Mylan
|
11 June 2020
|
| Trastuzumab
|
Powder for concentrate for solution for infusion, 150 mg
|
Samsung Bioepis
|
18 December 2019
|
| *The World Health Organization (WHO) does not give a strength for this in their list of PQ products.
|
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References
1. GaBI Online - Generics and Biosimilars Initiative. WHO launches consultation on prequalification of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-consultation-on-prequalification-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Celltrion/Teva launch trastuzumab biosimilar Herzuma in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-Teva-launch-trastuzumab-biosimilar-Herzuma-in-US
4. GaBI Online - Generics and Biosimilars Initiative.WHO prequalifies first rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-rituximab-biosimilar
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