Darbepoetin alfa biosimilars
A longer-acting red blood cell booster for anaemia in kidney disease and chemotherapy, with biosimilars in India and Japan and none in the West.
About darbepoetin alfa
Darbepoetin is a modified erythropoietin with extra sugar chains that keep it in the body about three times longer than epoetin, so it can be given weekly or fortnightly instead of several times a week.
Like epoetin it drives the bone marrow to make red blood cells. The extra sugar chains slow its removal from the blood, so fewer injections are needed.
An injection under the skin or into a vein every one to four weeks, adjusted to the patient's blood count.
Anaemia in chronic kidney disease and anaemia caused by chemotherapy.
A biosimilar is compared in the laboratory, especially its five sugar chains, in volunteers, and in a clinical study in kidney patients, as the Indian and Japanese approvals show.
The reference product is Aranesp, from Amgen, sold as Nesp in Japan by Kyowa Kirin.
Darbepoetin is a biosimilar market that exists only in Asia: three Indian makers since 2010, three Japanese approvals in 2019, and nothing in the West, where the epoetin biosimilars and newer long-acting drugs left little room.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todaysix darbepoetin alfa biosimilars are approved in at least one of the seven markets.
- Further outStimus is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from six to seven.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| PMDA | Darbepoetin Alfa BS [JCR] | JCR Pharmaceuticals | Sep 2019 | not published | Approved | S020 | |
| PMDA | Darbepoetin Alfa BS Sanwa | Sanwa Kagaku Kenkyusho | Sep 2019 | not published | Approved | S020 | |
| PMDA | Darbepoetin Alfa BS MYL | Mylan | Sep 2019 | not published | Approved | S020 | |
| CDSCO | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories Ltd | Mar 2010 | MF-246/10 | Approved | S014 | |
| CDSCO | Hetero Drugs (INN only) | Hetero Drugs Limited | Jan 2014 | MF-296/2013 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Jun 2016 | MF-91/2016 | Approved | S014 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for a darbepoetin alfa biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for darbepoetin alfa programmes. Regulatory strategy consulting
Presentations and concentration
Pre-filled syringes from 5 or 10 micrograms to 500 micrograms; Japanese biosimilars span 5 to 180 micrograms.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Dr. Reddy's darbepoetin alfa | · | · | · | · | · | Injection | · |
| Hetero darbepoetin alfa | · | · | · | · | · | Injection | · |
| Reliance Life Sciences darbepoetin alfa | · | · | · | · | · | Injection | · |
| Darbepoetin Alfa BS JCR | · | · | · | 5 to 180 microgram syringes | · | · | · |
| Darbepoetin Alfa BS Sanwa | · | · | · | 5 to 180 microgram syringes | · | · | · |
| Darbepoetin Alfa BS MYL | · | · | · | 5 to 180 microgram syringes | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Dr. Reddy's Laboratories | Dr. Reddy's darbepoetin alfa | · | · | · | · | · | ✓ | · |
| Hetero Drugs | Hetero darbepoetin alfa | · | · | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences darbepoetin alfa | · | · | · | · | · | ✓ | · |
| JCR Pharmaceuticals | Darbepoetin Alfa BS JCR | · | · | · | ✓ | · | · | · |
| Sanwa Kagaku Kenkyusho | Darbepoetin Alfa BS Sanwa | · | · | · | ✓ | · | · | · |
| Mylan (Viatris) | Darbepoetin Alfa BS MYL | · | · | · | ✓ | · | · | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Dr. Reddy's darbepoetin alfa
Hetero darbepoetin alfa
Reliance Life Sciences darbepoetin alfa
Darbepoetin Alfa BS JCR
Darbepoetin Alfa BS Sanwa
Darbepoetin Alfa BS MYL
In development
ClinicalTrials.gov holds one comparative trial of one darbepoetin alfa biosimilar candidate against the reference product, run by one sponsor. None of the candidates (Stimus) has an approval yet in any of the seven markets. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| Stimus | Nanogen | Aranesp | Phase 1 | Comparative PK | Completed | Sep 2021 | Nov 2022 | no approval in the seven markets | NCT05636891 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Is there a darbepoetin biosimilar in the United States or Europe?
No. None has been approved by FDA or EMA.
Which was the first darbepoetin biosimilar?
Dr. Reddy's product in India in 2010.
Which darbepoetin biosimilars are approved in Japan?
Three, all approved on the same day in 2019, from JCR, Sanwa and Mylan.
Is there a darbepoetin biosimilar in India?
Yes, three: Dr. Reddy's, Hetero and Reliance hold manufacturing permissions.
Is there a darbepoetin biosimilar in the UAE?
No. Aranesp is registered.
How is a darbepoetin biosimilar tested?
Laboratory comparison of the sugar chains, a volunteer study, and a clinical comparison in kidney patients.
Work with EvySaif on darbepoetin alfa
Darbepoetin alfa biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for darbepoetin alfa, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
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