Biosimilars of filgrastim

Biosimilars/General | Posted 20/03/2015 post-comment0 Post your comment

Last update: 22 January 2021

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.

Filgrastim V14K20

The originator product, Amgen’s Neupogen (filgrastim), was approved by the US Food and Drug Administration in February 1991 [1]. Neupogen had worldwide sales of US$1.4 billion in 2013 before the approval of the first filgrastim biosimilars, see Table 1.

The patents on Neupogen expired in the US in December 2013 and in Europe in 2006 [1]. Some of the filgrastim biosimilars approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of filgrastim approved or in development
Company name, Country Product name Stage of development
Kashiv BioSciences (previously Adello Biologics) - Accepted for review by FDA in September 2017 
Apotex (Apobiologix), Canada Grastofil Biosimilar approved in the EU in October 2013 for neutropenia [2]. Application for approval submitted to US FDA via abbreviated biosimilars pathway in February 2015.
Aryogen Biopharma, Iran* TinaGrast ‘Biogeneric’ marketed in Iran
Biocon, India* Nufil ‘Similar biologic’ marketed in India [3]
Biosidus, Argentina* Granulostim/ Neutromax Medicamento biológico similar approved in Argentina
Cadila Pharmaceutical, India* Filgrastim ‘Similar biologic’ approved in India in October 2013 [3]
Claris Life Sciences, India* Fegrast ‘Similar biologic’ marketed in India [3]
CT Arzneimittel, Germany Biograstim Biosimilar marketed in EU, where it was approved in September 2008 for cancer, haematopoietic stem cell transplantation, and neutropenia [2].
Dr Reddy’s Laboratories, India* Grafeel ‘Similar biologic’ marketed in India [3]
Eurofarma Laboratórios, Brazil Fiprima Follow-on biological approved in Brazil in October 2015 [4]
Hexal, Germany Filgrastim Hexal (EP2006) Biosimilar marketed in EU, where it was approved in February 2009 for cancer, haematopoietic stem cell transplantation and neutropenia [2].
Hospira (Pfizer), USA Nivestim (EU)/ Nivestym (US/Canada) Biosimilar marketed in EU, where it was approved in June 2010 for cancer, haematopoietic stem cell transplantation and neutropenia [2]. Approved by FDA in July 2018 [5]. Approved by Health Canada in April 2020 [6].
Intas Biopharmaceuticals, India* Neukine ‘Similar biologic’ approved in India in July 2004 [3]
Gennova Biopharmaceuticals (Emcure), India* Emgrast ‘Similar biologic’ approved in India in March 2010 [3]
Lupin, India* Lupifil ‘Similar biologic’ approved in India in March 2013 [3]
Merck (MSD) MK-4214 Phase III trial in breast cancer prematurely ended
PanGen Biotech, South Korea PHA30 Non-clinical trial completed
Pooyesh Darou Biopharmaceutical, Iran* PDGRASTIM ‘Biogeneric’ marketed in Iran
Ratiopharm, Germany Ratiograstim Biosimilar marketed in EU, where it was approved in September 2008 for cancer, haematopoietic stem cell transplantation and neutropenia [2].
Reliance Life Sciences, India* Religrast ‘Similar biologic’ approved in India in 2008 [3]
Sandoz, Switzerland Zarzio (EU)/Zarxio (USA) (EP2006) Biosimilar marketed in the EU where it was approved in February 2009 for cancer, haematopoietic stem cell transplantation and neutropenia [2]. Received Japanese approval in March 2014 [7]. Approved by FDA in March 2015 [5].
Stada Arzneimittel, Germany Grastofil Biosimilar in-licensed from Apotex in October 2013. Marketing expected to start in all the EU countries in 2014.
Tanvex BioPharma, Taiwan TX-01 Biosimilar application for approval submitted to US FDA in October 2018 and to Health Canada in January 2019. Rejected by US FDA in September 2019.
Teva Pharmaceutical Industries, Israel Tevagrastim Biosimilar marketed in the EU, where it was approved in September 2008 for cancer, haematopoietic stem cell transplantation and neutropenia [3]. Non-originator biological approved in South Africa in November 2017 [8].
USV, India* Filgrastim ‘Similar biologic’ approved in India in June 2013 [3]
EU: European Union; EMA: European Medicines Agency; FDA: US Food and Drug Administration.
*See editor’s comment 

Sandoz’s biosimilar filgrastim, Zarzio, is used in clinical practice in over 40 countries around the world. In fact, Zarzio is the number one biosimilar filgrastim globally. In 2013, it became the most prescribed daily G-CSF treatment in Europe overtaking originator products from Amgen (Neupogen) and Chugai (Granocyte) in terms of number of prescriptions [9].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted ‘similar biologics’ approved in India, ‘biogenerics’ approved in Iran, ‘medicamento biológico similares’ approved in Argentina, and non-originator biologicals approved in South Africa might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related article
Biosimilars of pegfilgrastim

References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India 
4. GaBI Online - Generics and Biosimilars Initiative. Filgrastim follow-on biological approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/News/Filgrastim-follow-on-biological-approved-in-Brazil
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilar filgrastim gains Japanese approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-filgrastim-gains-Japanese-approval
8. GaBI Online - Generics and Biosimilars Initiative. South Africa approves first non-originator biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 23]. Available from: www.gabionline.net/Biosimilars/News/South-Africa-approves-first-non-originator-biological
9. GaBI Online - Generics and Biosimilars Initiative. Biosimilar G-CSF prescribed more than originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-G-CSF-prescribed-more-than-originator

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Source: Amgen, EMA, EU Clinical Trials Register

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