Biosimilars of darbepoetin alfa

Biosimilars/General | Posted 01/08/2014 post-comment2 Post your comment

Last update: 20 November 2020

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.

Darbepoetin Alfa V13I06

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]. Collaborate with Taiwan-based Lotus Pharmaceutical to conduct clinical trials for sales licenses in Taiwan, Vietnam and Thailand [5].
Dong-A ST/Sanwa Kagaku Kenkyusho, South Korea/Japan DA‑3880 Submitted to Japan’s PMDA in October 2018 [6]
Dr Reddy’s Laboratories, India* Cresp ‘Similar biologic’ launched in India in March 2010 [7]
Kissei Pharmaceutical/JCR Pharmaceuticals, Japan JR-131 Positive results for phase III study reported in January 2018[8]
Kyowa Hakko Kirin, Japan Darbepoetin alfa injection syringe [KKF] Approved by Japan’s PMDA in August 2018 [9]
Torrent Pharmaceuticals, India* Darbatitor ‘Similar biologic’ launched in India in 2014 [7]
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

In Japan, darbepoetin alfa biosimilars from Kyowa Hakko Kirin (Darbepoetin alfa injection syringe [KKF]) [9] and Chong Kun Dang Pharmaceutical (CKD‑11101) [4] were approved in August and December 2018, respectively.

On 18 September 2020, Taiwan-based Lotus Pharmaceutical Co (Lotus) announced a long-term collaboration with Korea-based Chong Kun Dang Pharmaceutical Corp (CKD) for the distribution of biosimilar darbepoetin alfa (CKD-1110) in South East Asia [5].

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 that ‘similar biologics’ approved in India 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 epoetin alfa

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. 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. CKD Pharma’s darbepoetin alfa biosimilar launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/CKD-Pharma-s-darbepoetin-alfa-biosimilar-launched-in-Japan 
5.   GaBI Online - Generics and Biosimilars Initiative. Lotus to distribute CKD’s biosimilar darbepoetin alfa in South East Asia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Pharma-News/Lotus-to-distribute-CKD-s-biosimilar-darbepoetin-alfa-in-South-East-Asia  
6.   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 
7.   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
8.   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
9.   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
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

comment icon Comments (2)
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Posted 24/09/2014 by Justyna K, GaBI Online Editorial Office
Response to ‘Regarding Darbepoetin alfa’

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

Posted 07/08/2014 by Prasad
Regarding Darbepoetin alfa

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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