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Biosimilars of pegfilgrastim Posted 31/10/2014

Last update: 8 September 2017

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

The originator product, Amgen’s Neulasta (pegfilgrastim), was approved by the US Food and Drug Administration (FDA) in January 2002 and by the European Medicines Agency (EMA) in August 2002 [1]. Neulasta had worldwide sales of US$4.7 billion in 2016.

The patents on Neulasta expired in the US in October 2015 and will expire in Europe in August 2017 [1]. Some of the pegfilgrastim biosimilars approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of pegfilgrastim approved or in development

Company name, Country

Product name

Stage of development

Adello Biologics

TPI‑120

Phase I [2]

Apotex (Apobiologix), Canada

Lapelga

Submitted for approval in the US in December 2014 [3]

Biocon/Mylan, India*/USA

MYL-1401H

Submitted to EMA for approval in July 2016 [4]. Withdrawn from EMA August 2017 [5]

Cinfa Biotech, Spain

B12019

Completed two phase II trials in healthy subjects [6]

Coherus, USA

CHS-1701

Positive results from phase I trials announced in October 2015 [7] and July 2016 [8]. Submitted to FDA in October 2016 [9] and to EMA in November 2016 [10]. Rejected by FDA 12 June 2017 [11]

Dr Reddy’s Laboratories, India*

Peg-grafeel

‘Similar biologic’ approved in India in May 2010 [12]

Intas Biopharmaceuticals, India*

Neupeg

‘Similar biologic’ approved in India in August 2007 [12]

Gennova Biopharmaceuticals (Emcure), India*

Pegex

‘Similar biologic’ approved in India in January 2010 [12]

Lupin, India*

Peg-filgrastim

‘Similar biologic’ approved in India in September 2013 [12]

Pfenex, USA

PF529

Candidate biosimilar under pre-clinical development

Pfizer

HSP-130

Phase I

Sandoz, Switzerland

LA-EP2006

Filed for approval in the US in November 2015 [13] and in the EU in February 2016 [14]. Rejected by FDA July 2016 [15] and withdrawn from EMA January 2017 [16]

Siam Bioscience, Thailand

SBS 6002

Positive results for CMC analytical and non-clinical biosimilarity studies reported in July 2017

Stada Arzneimittel/Gedeon Richter, Germany/Hungary

-

Submitted to EMA for approval in December 2015 [17]

EU: European Union; EMA: European Medicines Agency; FDA: US Food and Drug Administration.
*See editor’s comment

Generics maker Sandoz was one of the frontrunners in the race to biosimilar pegfilgrastim. The company has already completed two phase III trials comparing biosimilar pegfilgrastim to Amgen’s Neulasta in breast cancer patients [17]. Sandoz filed for approval of its pegfilgrastim biosimilar (LA-EP2006) in the US in November 2015 [12] and in the EU in February 2016 [13]. However, after a rejection by the FDA [14] and withdrawing its application to the EMA [15], things are no longer looking so rosy and its competitors are fast catching up. Canada-based Apotex filed for approval of its pegfilgrastim biosimilar in the US in December 2014 [2]. Biocon/ Mylan submitted an application for approval of its pegfilgrastim biosimilar to EMA in July 2016 [3]. Stada Arzneimittel/Gedeon Richter, submitted an application for approval of its pegfilgrastim biosimilar to the EMA in December 2015 [16]. Coherus submitted applications for approval of its pegfilgrastim biosimilar to FDA in October 2016 [8] and to EMA in November 2016 [9]. Coherus also received a rejection from FDA in June 2017 [10].

Biocon/Mylan are also experiencing setbacks after they were required to withdraw their application from EMA as part of ‘procedural requirements’ after implementation of corrective and preventive actions and re-inspection of Biocon’s ‘Drug Product facility’ in Bangalore were required before a good manufacturing practice (GMP) compliance certificate could be issued for the site. The companies expect to re-submit their application by the end of September 2017 [5].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

Related article
Biosimilars of filgrastim

References
1. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Adello Biologics starts phase I trial for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/Research/Adello-Biologics-starts-phase-I-trial-for-pegfilgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review 
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 2]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
5. GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8].
6. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: http://www.gabionline.net/Biosimilars/News/Positive-phase-I-results-for-Cinfa-s-pegfilgrastim-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 23]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-pegfilgrastim-biosimilar
8. GaBI Online - Generics and Biosimilars Initiative. More positive phase I results for Coherus pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-I-results-for-Coherus-pegfilgrastim-biosimilar
9. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
10. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
11. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgratim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus
12. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India 
13. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
14. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar
15. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
16. GaBI Online - Generics and Biosimilars Initiative. Sandoz withdraws biosimilar pegfilgrastim applicationbiosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-withdraws-biosimilar-pegfilgrastim-application
17. GaBI Online - Generics and Biosimilars Initiative. Richter and DM Bio make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Pharma-News/Richter-and-DM-Bio-make-deal-for-trastuzumab-biosimilar
18. GaBI Online - Generics and Biosimilars Initiative. Sandoz advances biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-advances-biosimilars-pipeline

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Source: Amgen, EMA, CDSCO

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