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 the 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), approvedon 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.
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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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