Epoetin alfa and zeta biosimilars
A copy of the hormone that makes red blood cells, used for anaemia in kidney disease and chemotherapy, and the molecule on which Europe's biosimilar rules were written.
About epoetin alfa and zeta
Epoetin is a manufactured version of erythropoietin, the hormone the kidneys make to tell the bone marrow to produce red blood cells. People with kidney failure or on chemotherapy cannot make enough, and epoetin replaces it.
It binds the erythropoietin receptor on cells in the bone marrow and drives them to become red blood cells. The sugar chains attached to the protein control how long it lasts in the body, and they are the hardest part to copy.
An injection under the skin or into a vein, one to three times a week, adjusted to the patient's blood count.
Anaemia in chronic kidney disease, anaemia caused by chemotherapy, and reducing the need for transfusion around surgery.
Rarely, antibodies to epoetin can cause a serious loss of red cell production, and a change in the original product's formulation once triggered a cluster of cases. That history shaped biosimilar rules everywhere. A biosimilar is compared closely in the laboratory, especially its sugar chains, in volunteers, and in a clinical study in kidney patients.
The reference products are Eprex in Europe and Epogen and Procrit in the United States. Europe's first biosimilars came in 2007. The two European products share the same protein but were given slightly different names because their sugar chains differ.
The first biosimilar rules were written for epoetin, and it remains the deepest Indian segment in the Atlas, with more than a dozen firms holding permissions. In the West the market has one US biosimilar and a small European group, and much of the volume has moved to longer-acting versions.
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
- Todayten epoetin alfa and zeta biosimilars are approved in at least one of the seven markets.
- Nearest to marketEPIAO, UB-851 have reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from ten to twelve.
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 |
|---|---|---|---|---|---|---|---|
| FDA | Retacrit | Hospira Inc., a Pfizer Company | May 2018 | 125545 | Biosimilar | Approved | S001, S016 |
| EMA | Epoetin alfa Hexal | Hexal AG | Aug 2007 | EMEA/H/C/000726 | Approved | S017 | |
| EMA | Abseamed | Medice Arzneimittel Pütter GmbH Co. KG | Aug 2007 | EMEA/H/C/000727 | Approved | S017 | |
| EMA | Binocrit | Sandoz GmbH | Aug 2007 | EMEA/H/C/000725 | Approved | S017 | |
| EMA | Silapo | Stada Arzneimittel AG | Dec 2007 | EMEA/H/C/000760 | Approved | S017 | |
| EMA | Retacrit | Pfizer Europe MA EEIG | Dec 2007 | EMEA/H/C/000872 | Approved | S017 | |
| MHRA | Abseamed | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Retacrit | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Epoetin Alfa BS [JCR] | JCR Pharmaceuticals | Jan 2010 | not published | Approved | S020 | |
| CDSCO | Biocon (INN only) | Biocon Limited | Aug 2006 | Import permission | Approved | S013 | |
| CDSCO | Reliance Biopharmaceuticals (INN only) | Reliance Biopharmaceuticals | Jan 2008 | Import permission | Approved | S013 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | Apr 2010 | MF-406/10 | Approved | S014 | |
| CDSCO | Bioviz Technologies (INN only) | Bioviz Technologies Pvt Ltd | Aug 2011 | MF-333/11 | Approved | S014 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Aug 2011 | Import permission | Approved | S013 | |
| CDSCO | Cipla (INN only) | Cipla Limited | Nov 2021 | IMP/BIO/21/000096 | Approved | S012 | |
| CDSCO | Wockhardt (INN only) | Wockhardt Limited | Feb 2023 | MF/BIO/23/000006 | Approved | S011 | |
| EDE | Binocrit | Sandoz GmbH TechOps, Austria | Sep 2018 | not published | Registered | S018 |
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 an epoetin alfa and zeta 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 epoetin alfa and zeta programmes. Regulatory strategy consulting
Presentations and concentration
Pre-filled syringes and vials from 1,000 IU to 40,000 IU. Epoetin alfa (Binocrit family) and epoetin zeta (Silapo, Retacrit) are the same protein with different glycosylation and are not interchangeable by INN.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Binocrit / Epoetin alfa Hexal / Abseamed HX575 | · | see SmPC | 1,000 to 40,000 IU syringes | · | · | · | 1,000 IU/0.5 mL to 40,000 IU/mL PFS |
| Retacrit / Silapo | 2,000 to 40,000 units/mL vials | see SmPC | 1,000 to 40,000 IU syringes | · | · | · | · |
| Zydus epoetin | · | · | · | · | · | Lyophilised injection | · |
| Bioviz epoetin | · | · | · | · | · | 2,000 and 4,000 IU/mL PFS | · |
| Wockhardt epoetin | · | · | · | · | · | Injection | · |
| Biocon epoetin | · | · | · | · | · | 2,000, 4,000 and 10,000 IU vials | · |
| Reliance epoetin | · | · | · | · | · | 10,000 IU/mL PFS | · |
| Lupin epoetin | · | · | · | · | · | 2,000 to 10,000 IU PFS | · |
| Cipla epoetin | · | · | · | · | · | Vials and PFS | · |
| Epoetin Alfa BS JCR | · | · | · | 750, 1,500 and 3,000 IU syringes | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Sandoz | Binocrit / Epoetin alfa Hexal / Abseamed | · | ✓ | ✓ | · | · | · | ✓ |
| Norbitec (Stada and Hospira) | Retacrit / Silapo | ✓ | ✓ | ✓ | · | · | · | · |
| Cadila Healthcare (Zydus Lifesciences) | Zydus epoetin | · | · | · | · | · | ✓ | · |
| Bioviz Technologies | Bioviz epoetin | · | · | · | · | · | ✓ | · |
| Wockhardt | Wockhardt epoetin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Biocon epoetin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Reliance epoetin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Lupin epoetin | · | · | · | · | · | ✓ | · |
| Not stated in the CDSCO list | Cipla epoetin | · | · | · | · | · | ✓ | · |
| JCR Pharmaceuticals | Epoetin Alfa BS JCR | · | · | · | ✓ | · | · | · |
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
Binocrit / Epoetin alfa Hexal / Abseamed
Retacrit / Silapo
Zydus epoetin
Bioviz epoetin
Wockhardt epoetin
Biocon epoetin
Reliance epoetin
Lupin epoetin
Cipla epoetin
Epoetin Alfa BS JCR
In development
ClinicalTrials.gov holds three comparative trials of two epoetin alfa and zeta biosimilar candidates against the reference product, run by two sponsors. None of the candidates (EPIAO, UB-851) 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 |
|---|---|---|---|---|---|---|---|---|---|
| EPIAO | 3SBio | Eprex | Phase 4 | Comparative | Terminated | Aug 2015 | Jun 2019 | no approval in the seven markets | NCT02522975 |
| EPIAO | 3SBio | Eprex | Phase 3 | Comparative efficacy | Completed | Dec 2015 | Oct 2021 | no approval in the seven markets | NCT02947438 |
| UB-851 | UBI Pharma | Eprex | Phase 3 | Comparative efficacy | Completed | Mar 2016 | Oct 2021 | no approval in the seven markets | NCT02708914 |
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
Why are there two names, epoetin alfa and epoetin zeta?
They are the same protein. Europe gave the Stada and Hospira product a separate name because its sugar chains differ from the reference. In the United States the same product is called epoetin alfa.
Is there an epoetin biosimilar in the United States?
One: Retacrit, from Pfizer's Hospira, since 2018.
Which Indian companies make epoetin?
Many. Wockhardt, Intas and Shantha had products before the published lists begin; the lists show Zydus, Bioviz and Wockhardt as manufacturers and Biocon, Reliance, Lupin and Cipla among importers.
Which epoetin biosimilars are registered in the UAE?
Sandoz's Binocrit, alongside Eprex.
How is an epoetin biosimilar tested?
Detailed laboratory comparison of the sugar chains, a volunteer study, a clinical comparison in kidney patients by both routes, and follow-up for immune reactions.
Why was epoetin so important for biosimilar rules?
A formulation change in the original once caused a rare immune reaction that stopped red cell production. Regulators saw that small manufacturing differences matter, and wrote the first biosimilar guidelines around this molecule.
Work with EvySaif on epoetin alfa and zeta
Epoetin alfa and zeta 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 epoetin alfa and zeta, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S001FDA, Biosimilar Product Information (approved biosimilars table) 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)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) 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)
Planning epoetin alfa and zeta biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultant