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Canada approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 14/01/2022 0 Post your comment

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Nypozi is a biosimilar of Amgen’s Neupogen (filgrastim). Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

Nypozi was developed by Taiwan-based biosimilars maker Tanvex Biopharma (Tanvex). The application for approval was submitted to Health Canada back in January 2019 [1] and the biosimilar was approved on 8 October 2021 as a solution for both intravenous and subcutaneous injection at doses of 300 μg/0.5 mL and 480 μg/0.8 mL.

There are already two other filgrastim biosimilars approved in Canada. Apotex’s Grastofil was the first to be approved in December 2015, followed by Pfizer’s Nivestym in April 2020 [2].

The approval of Nypozi marks the first biosimilar from Tanvex to be approved in Canada.

The company had also submitted an application for approval of its candidate filgrastim biosimilar (TX01) to the US Food and Drug Administration in October 2018, but this was rejected in September 2019 [3].

LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos en América Latina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Tanvex BioPharma submits filgrastim biosimilar to Health Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/news/Tanvex-BioPharma-submits-filgrastim-biosimilar-to-Health-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 14]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim

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Source: Health Canada