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Biosimilars of darbepoetin alfa Posted 01/08/2014

Last update: 1 February 2019

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]. Amgen co-developed the product with Japan-based Kyowa Hakko Kirin, which sells the drug in Japan and other Asian countries as Nesp. Aranesp had sales of US$2.1 billion in 2016, despite the presence of biosimilars, see Table 1.

The patents on Aranesp will expire in the US in May 2024 and expired in Europe in July 2016 [1]. Despite patent protection, biosimilar competitors have been on the market in Europe since 2007. 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 III and Phase IV and SC studies completed in June 2017 and August 2017, respectively. Approved by Japan’s MHLW in December 2018 [4].

Dong-A ST/Sanwa Kagaku Kenkyusho, South Korea/Japan

DA‑3880

Submitted to Japan’s PMDA in October 2018 [5]

Dr Reddy’s Laboratories, India*

Cresp

‘Similar biologic’ launched in India in March 2010 [6]

Kissei Pharmaceutical/JCR Pharmaceuticals, Japan

JR-131

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

Kyowa Hakko Kirin, Japan

Darbepoetin alfa injection syringe [KKF]

Approved by Japan’s PMDA in August 2018 [8]

Torrent Pharmaceuticals, India*

Darbatitor

‘Similar biologic’ launched in India in 2014 [6]

Merck, USA

MK-2578

Development halted in 2010 [10]

IV: intra-venous; PMDA: Pharmaceuticals and Medical Devices Agency; SC: sub-cutaneous.
*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.

In Japan, darbepoetin alfa biosimilars from Kyowa Hakko Kirin (Darbepoetin alfa injection syringe [KKF]) [8] and Chong Kun Dang Pharmaceutical (CKD‑11101) [5] have were approved in August and December 2018, respectively.

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.   Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
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. Trastuzumab and agalsidase beta biosimilars launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-and-agalsidase-beta-biosimilars-launched-in-Japan
5.   GaBI Online - Generics and Biosimilars Initiative. Two darbepoetin alfa biosimilars submitted to Japan’s PMDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Two-darbepoetin-alfa-biosimilars-submitted-to-Japan-s-PMDA
6.   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
7.   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
8.   GaBI Online - Generics and Biosimilars Initiative. Japan approves first darbepoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-first-darbepoetin-alfa-biosimilar
9.   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
10.   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.

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