Editing Filgrastim (section)

==Society and culture==

===Biosimilars===
{{see also|Biosimilars}}

In 2015, Sandoz's filgrastim-sndz (Zarxio), obtained the approval of the US [[Food and Drug Administration]] (FDA) as a biosimilar.<ref name="FDA_Zarxio_2015">{{cite press release |date=6 March 2015 |access-date=23 November 2015 |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm |title=FDA approves first biosimilar product Zarxio |work=U.S. [[Food and Drug Administration]] (FDA) |url-status=dead |archive-url=https://web.archive.org/web/20151211053044/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm |archive-date=11 December 2015 }}</ref><ref>{{cite web | title=Zarxio (filgrastim-sndz) | website=U.S. [[Food and Drug Administration]] (FDA) | date=20 April 2015 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | archive-url=https://web.archive.org/web/20191220184811/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | archive-date=20 December 2019 | url-status=dead | access-date=20 December 2019}}</ref><ref name="NYT_Zarxio">{{cite news | vauthors = Tavernise S, Pollack A |title=F.D.A. Approves Zarxio, Its First Biosimilar Drug |url=https://www.nytimes.com/2015/03/07/health/fda-approves-zarxio-first-biosimilar-drug.html |newspaper=[[The New York Times]] |date=6 March 2015 |access-date=23 November 2015 |url-status=live |archive-url=https://web.archive.org/web/20151023143537/http://www.nytimes.com/2015/03/07/health/fda-approves-zarxio-first-biosimilar-drug.html |archive-date=23 October 2015 }}</ref> This was the first product to be passed under the [[Biologics Price Competition and Innovation Act of 2009]] (BPCI Act), as part of the [[Affordable Care Act]].<ref name="FDA_Zarxio_2015" /> Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.<ref name="NYT_Zarxio" />

In 2018, filgrastim-aafi (Nivestym) was approved for use in the United States.<ref name="Nivestym Drug Approval Package">{{cite web | title=Drug Approval Package: Nivestym (filgrastim-aafi) | website=U.S. [[Food and Drug Administration]] (FDA) | date=21 February 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | archive-url=https://web.archive.org/web/20191220184614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | archive-date=20 December 2019 | url-status=dead | access-date=20 December 2019}}</ref>

In September 2008, Ratiograstim, Tevagrastim, Biograstim, and Filgrastim ratiopharm were approved for use in the European Union.<ref name="Ratiograstim EPAR">{{cite web | title=Ratiograstim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | access-date=2 April 2020 | archive-date=14 August 2020 | archive-url=https://web.archive.org/web/20200814211722/https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | url-status=live }}</ref><ref>{{cite web | title=Tevagrastim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | access-date=2 April 2020 | archive-date=16 October 2019 | archive-url=https://web.archive.org/web/20191016120016/https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | url-status=live }}</ref><ref name="Biograstim EPAR">{{cite web | title=Biograstim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Biograstim | access-date=2 April 2020 | archive-date=22 October 2020 | archive-url=https://web.archive.org/web/20201022204309/https://www.ema.europa.eu/en/medicines/human/EPAR/biograstim | url-status=live }}</ref><ref>{{cite web | title=Filgrastim ratiopharm EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | access-date=2 April 2020 | archive-date=21 January 2021 | archive-url=https://web.archive.org/web/20210121002356/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | url-status=live }}</ref> Filgrastim ratiopharm was withdrawn in July 2011 and Biograstim was withdrawn in December 2016.

In February 2009, Filgrastim Hexal and Zarzio were approved for use in the European Union.<ref>{{cite web | title=Filgrastim Hexal EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | access-date=2 April 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161956/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | url-status=live }}</ref><ref name="Zarzio EPAR">{{cite web | title=Zarzio EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | access-date=20 December 2019 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015190413/https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | url-status=live }}</ref>

In June 2010, Nivestim was approved for use in the European Union.<ref name="Nivestim EPAR">{{cite web | title=Nivestim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | access-date=20 December 2019 | archive-date=20 December 2019 | archive-url=https://web.archive.org/web/20191220191624/https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | url-status=live }}</ref>

In October 2013, Grastofil was approved for use in the European Union.<ref name="Grastofil EPAR">{{cite web | title=Grastofil EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | access-date=2 April 2020 | archive-date=12 November 2020 | archive-url=https://web.archive.org/web/20201112002249/https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | url-status=live }}</ref>

In September 2014, Accofil was approved for use in the European Union.<ref name="Accofil EPAR">{{cite web | title=Accofil EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | access-date=2 April 2020 | archive-date=23 March 2020 | archive-url=https://web.archive.org/web/20200323235656/https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | url-status=live }}</ref>

In 2016, Fraven was approved for use by Republic of Turkey ministry of health.<ref>{{cite web | url = http://finans.gazetevatan.com/haber-detay/gundem/arven-ilac--turkiyenin-ilk-biyobenzer-urununu-uretti/48936/%7Ctitle=Arven%20ila%C3%A7 | archive-url = https://web.archive.org/web/20230211063004/https://finans.gazetevatan.com/haber-detay/gundem/arven-ilac--turkiyenin-ilk-biyobenzer-urununu-uretti/48936/%7Ctitle=Arven%20ila%C3%A7 | archive-date=11 February 2023 | title = Arven ilaç, Türkiyenin ilk biyobenzer ürününü üretti | trans-title = Arven Pharmaceuticals produced Turkey's first biosimilar product | language = Turkish | work = Vatan Finans }}</ref><ref>{{cite web | title=Products | website=Arven İlaç | url=https://arvenilac.com.tr/en/products/index.html | access-date=30 August 2024}}</ref>

Nivestym was approved for medical use in Canada in April 2020.<ref name="Nivestym SBD">{{cite web | title=Summary Basis of Decision (SBD) for Nivestym | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00486&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530213145/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00486&lang=en | url-status=live }}</ref>

In October 2021, Nypozi was approved for medical use in Canada.<ref name="Nypozi SBD">{{cite web | title=Summary Basis of Decision (SBD) for Nypozi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00569&lang=en | access-date=29 May 2022 | archive-date=25 September 2022 | archive-url=https://web.archive.org/web/20220925201028/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00569&lang=en | url-status=live }}</ref>

In February 2022, filgrastim-ayow (Releuko) was approved for medical use in the United States.<ref name="Releuko FDA label" /><ref>{{cite web | title=Drug Approval Package: Releuko | website=U.S. [[Food and Drug Administration]] (FDA) | date=11 April 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm | access-date=2 July 2024}}</ref>

In June 2024, filgrastim-txid (Nypozi) was approved for medical use in the United States.<ref name="Nypozi FDA label">[https://web.archive.org/web/20240702042112/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761126s000lbl.pdf fda.gov] {{Bare URL PDF|date=August 2024}}</ref>

In December 2024, the [[Committee for Medicinal Products for Human Use]] of the [[European Medicines Agency]] adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zefylti, intended for the treatment of neutropenia and the mobilization of peripheral blood progenitor cells.<ref name="Zefylti EPAR" /> The applicant for this medicinal product is CuraTeQ Biologics s.r.o.<ref name="Zefylti EPAR" /> Zefylti is a biosimilar medicinal product.<ref name="Zefylti EPAR" /> It is highly similar to the reference product Neupogen (filgrastim), which has been authorized in various EU countries.<ref name="Zefylti EPAR">{{cite web | title=Zefylti EPAR | website=[[European Medicines Agency]] (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Zefylti was authorized for medical use in the European Union in February 2025.<ref name="Zefylti PI">{{cite web | title=Zefylti PI | website=Union Register of medicinal products | date=14 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1899.htm | access-date=16 February 2025}}</ref>

===Economics===
Shortly after it was introduced, analyses of whether filgrastim is a cost-effective way of preventing [[febrile neutropenia]] depended upon the clinical situation and the financial model used to pay for treatment.<ref>{{Cite book| vauthors = Neymark N |title=Assessing the Economic Value of Anticancer Therapies  |journal=Recent Results in Cancer Research. Fortschritte der Krebsforschung. Progres dans les Recherches Sur le Cancer |series=Recent Results in Cancer Research|date=1998|volume=148|publisher=Springer |isbn=978-3-642-72123-6|location=Berlin, Heidelberg|pages=215–219|doi=10.1007/978-3-642-72123-6|pmid=9670279|s2cid=34894897|oclc=851760173}}</ref> The longer-acting [[pegfilgrastim]] may in some cases be more cost-effective.<ref>{{Cite book| vauthors = Ellery T |title=Pharmaceutical lifecycle management : making the most of each and every brand|date=2012|publisher=John Wiley & Sons|others=Hansen, Neal.|isbn=978-1-118-26679-3|location=Hoboken, N.J.|pages=214|oclc=797824835}}</ref>