FDA approves filgrastim biosimilar Nypozi

In addition to the biosimilars approval of Pyzchiva (ustekinumab-ttwe), with a provisional determination for interchangeability designation [1], and Ahzantive (aflibercept-mrbb) [2] on 28 June 2024, the US Food and Drug Administration (FDA) also approved Tanvex BioPharma’s Nypozi (filgrastim-txid) biosimilar, which references Amgen’s Neupogen.

This makes Nypozi the third biosimilars approved by FDA on 28 June 2024, bringing the total number of biosimilars approved in the US to 55 [3].

Nypozi (TX01), a proposed biosimilar to the reference product Neupogen, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

Nypozi (filgrastim-txid) is approved in the formulations of 300 mcg/0.5 mL and 480 mcg/0.8 mL.

The FDA approval for Tanvex’s Nypozi marks Taiwan’s debut or Asia’s first filgrastim biosimilar in the US market. This approval is the fourth FDA approval for a filgrastim biosimilar, following Kashiv Biosciences’ Releuko (filgrastim-ayow), approved on 25 February 2022 [4]; Pfizer’s Nivestym (filgrastim-aafi), approved on 20 July 2018 [5]; and Sandoz’s Zarxio (filgrastim-sndz), approved on 6 March 2015 [6].

Nypozi (TX01) was approved in Canada in early 2022 [7] and launched in January 2024.

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 [8]. Filgrastim is sold under the brand name Neupogen by originator company Amgen.

According to IQVIA data from March 2024, the US filgrastim market is valued at US$403 million, with Canada following at US$65 million.

Aside from Tanvex, major players in the filgrastim biosimilars market include Cadila Pharmaceuticals, Dr Reddy’s Laboratories, Intas Biopharmaceuticals, Sandoz, and Emcure Pharmaceuticals Ltd.

Tanvex BioPharma submits filgrastim biosimilar to Health Canada

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves third ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves Kashiv Biosciences’ filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/fda-approves-kashiv-biosciences-filgrastim-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves filgrastim biosimilar Nivestym [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-filgrastim-biosimilar-Nivestym
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-its-first-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Canada approves filgrastim biosimilar Nypozi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/news/canada-approves-filgrastim-biosimilar-nypozi
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 4]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim

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