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Biosimilars of pegfilgrastim Posted 31/10/2014

Last update: 22 November 2019

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, before the advent of biosimilars.

The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [1]. Some of the pegfilgrastim biosimilars and non-originator biologicals* 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, USA

TPI‑120

Phase I

Apotex (Apobiologix)/Intas Biopharmaceuticals/Accord Healthcare, Canada/India*/USA

Lapelga (Canada)/Neupeg (India)/Pelgraz (EU) (Apo-Peg)

‘Similar biologic’ approved in India in August 2007 [2]. Approved by EC in September 2018 [3]. Submitted for approval in the US in December 2014 [4]. Approved in Canada in May 2018 [5]  

Biocon/Mylan, India*/USA

Fulphila (MYL-1401H)

Approved by FDA in June 2018 [6]. Approved by EC in January 2019 [3]. Launched in US in November 2018

Cadila Healthcare, India*

-

Plans to file for approval in US by end 2019

Cinfa Biotech/Mundipharma [7], Spain/UK

Pelmeg (B12019)

Pelmeg approved by EC in November 2018 [ 3]. Pegfilgrastim Mundipharma approved by EMA in October 2019 [3]

Chong Kun Dang Pharmaceutical, South Korea

CKD-12101

Preclinical

Coherus Biosciences, USA

Udenyca (CHS-1701)

Approved by EC in September 2018 [3] and by FDA in November 2018 [6]. Launched in US in November 2018

Dr Reddy’s Laboratories, India*

Peg-grafeel

‘Similar biologic’ approved in India in May 2010 [2]

Fresenius Kabi, Germany 

MSB11455 

Acquired from Merck KGaA in September 2017. Positive phase I results reported in October 2018.

Gennova Biopharmaceuticals (Emcure), India*

Pegex

‘Similar biologic’ approved in India in January 2010 [2]

Lupin, India*

Peg-filgrastim

‘Similar biologic’ approved in India in September 2013 [2]

Pfenex, USA

PF529

Candidate biosimilar under pre-clinical development

Pfizer, USA

HSP-130

Phase I

Sandoz, Switzerland

Ziextenzo (LA-EP2006)

Approved by EC in November 2018 [3]. Approved by FDA in November 2019 [8]

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 [9]. Application withdrawn from EMA in December 2016. Resubmitted to EMA in March 2018 [10].

USV, India*

-

Approval received from DCGI to initiate phase III clinical studies in India. Phase III clinical studies in Europe initiated in September 2015. Pre-IND meeting with FDA held. Phase I in US planned. 

CMC: Chemistry and Manufacturing Controls; CRL: Complete Response Letter; DCGI: Drug Controller General of India; EU: European Union; EMA: European Medicines Agency; FDA: US Food and Drug Administration.
*See editor’s comment

Developers of pegfilgrastim biosimilars have not had an easy route, with a whole host of rejected applications littering the way. However, the path finally seems to have cleared with approvals now coming thick and fast.

Biocon/Mylan initially had to withdraw their application from the EMA and received a rejection from the FDA. However, they finally received approval for Fulphila from the FDA in June 2018 [6] and from the EC in September 2018 [3].

Generics maker Sandoz was also rejected by the FDA and withdrew its application from the EMA, but received EC approval for Ziextenzo in November 2018 [3] and FDA approval in November 2019 [6].

Canada-based Apotex filed for approval of its pegfilgrastim biosimilar in the US in December 2014 and received approval for Lapelga in Canada[9], but withdrew it in December 2016 and for Pelgraz from the EC in July 2018 [3].

Stada Arzneimittel/Gedeon Richter, submitted an application for approval of its pegfilgrastim biosimilar to the EMA in December 2015 [9], but withdrew it in December 2016 and resubmitted it in March 2018 [10]. Coherus submitted applications for approval of its pegfilgrastim biosimilar to FDA in October 2016 and to EMA in November 2016. Coherus also received a rejection from FDA in June 2017 but received EC approval in September 2018 [3] and FDA approval in November 2018 [6]. UK-based Mundipharma International and Spain-based Cinfa Biotech received EC approval for Pelmeg in November 2018 and for Pegfilgrastim Mundipharma in October 2019 [3].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘medicamento biológico similares’ approved in Argentina 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 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. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe. EMA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. 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 
5. GaBI Online - Generics and Biosimilars Initiative. Pegfilgrastim biosimilar Lapelga approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/Pegfilgrastim-biosimilar-Lapelga-approved-in-Canada 
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. Mundipharma buys Spanish biosimilars’ maker Cinfa Biotech [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Pharma-News/Mundipharma-buys-Spanish-biosimilars-maker-Cinfa-Biotech
8. GaBI Online - Generics and Biosimilars Initiative. FDA approves pegfilgrastim biosimilar Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-pegfilgrastim-biosimilar-Ziextenzo
9. GaBI Online - Generics and Biosimilars Initiative. Stada resubmits biosimilar pegfilgrastim but stops adalimumab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Pharma-News/Stada-resubmits-biosimilar-pegfilgrastim-but-stops-adalimumab-development

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Source: Amgen, EMA, CDSCO

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