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Biosimilars of darbepoetin alfa Posted 01/08/2014

Last update: 9 March 2018

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

The originator product, Amgen’s Aranesp (darbepoetin alfa), was approved by the US Food and Drug Administration (FDA) in September 2001 and by the European Medicines Agency (EMA) in August 2001 [1]. Aranesp had sales of US$1.9 billion in 2014, therefore, its not surprising that biosimilar developers have targeted the drug, see Table 1.

The patents on Aranesp expire in the US in May 2024 and in Europe in July 2016 [1]. Despite this fact, biosimilar competitors are already on the market in Europe, Some of the darbepoetin alfa biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

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

Company name, Country

Product name

Stage of development

Avesthagen Pharma (APAG), India*

Avdesp

Agreement with Greece-based ElpenPharmaceutical [2]

Cipla/Hetero Drugs, India*

Actorise

‘Similar biologic’ launched in India in June 2014 [3]

Chong Kun Dang Pharmaceutical, South Korea

CKD-11101

Phase I pharmacokinetics study completed. Phase III clinical study planned to start end 2014 [4]

Dr Reddy’s Laboratories, India*

Cresp

‘Similar biologic’ launched in India in March 2010 [5]

Kissei Pharmaceutical/JCR Pharmaceuticals, Japan

JR-131

Positive results for phase III study announced in January 2018 [6]

Torrent Pharmaceuticals, India*

Darbatitor

‘Similar biologic’ launched in India in 2014 [5]

Hospira, USA

Retacrit (epoetin zeta)

Approved in Europe in December 2007 [7]. Submitted for approval in USA in December 2014 [8]

Merck, USA

MK-2578

Development halted in 2010 [9]

Stada, Germany

Silapo (epoetin zeta)

Approved in Europe in December 2007 [7]

* See editor’s comment

Both Hospira’s Retacrit and Stada’s Silapo have been approved by EMA for the same indications as Aranesp, i.e. anaemia, cancer and chronic kidney failure, as well as for autologous blood transfusion.

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 epoetin alfa

References
1.   GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2.   GaBI Online - Generics and Biosimilars Initiative. Avesthagen and Elpen make deal for biosimilar darbepoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/News/Avesthagen-and-Elpen-make-deal-for-biosimilar-darbepoetin-alfa
3.   GaBI Online - Generics and Biosimilars Initiative. Darbepoetin alfa ‘similar biologic’ launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/News/Darbepoetin-alfa-similar-biologic-launched-in-India
4.   GaBI Online - Generics and Biosimilars Initiative. Phase I study shows darbepoetin alfa biosimilar to be well tolerated [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 6]. Available from: www.gabionline.net/Biosimilars/Research/Phase-I-study-shows-darbepoetin-alfa-biosimilar-to-be-well-tolerated 
5.   GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
6.   GaBI Online - Generics and Biosimilars Initiative. Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 9]. Available from: www.gabionline.net/Biosimilars/Research/Kissei-JCR-s-darbepoetin-alfa-biosimilar-shows-equivalent-safety-and-efficacy
7.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
8.   GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 12]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar 
9.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars’ hurdles in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-hurdles-in-the-US

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Source: EMA

Comments (2)

Response to ‘Regarding Darbepoetin alfa’ posted 24/09/2014 - by Justyna K, GaBI Online Editorial Office

Dear Mr Prasad, Thank you for your comments. We have updated the article with Hetero Drugs added. Regarding Avasthagen's darbepoetin alfa, indeed, that was the information we presented in the original article content. Please feel free to send us your further updates on this news article. Best regards, Justyna

Regarding Darbepoetin alfa posted 07/08/2014 - by Prasad

In India, Hetero Drugs Ltd launched the Darbepoetin alfa recently and it was in indian market. Even Avasthagen Darbepoetin alfa was not marketing in india. Thank you.