Eculizumab biosimilars
A treatment for two rare blood disorders, among the most expensive medicines in the world, with two biosimilars in the United States and Europe and none elsewhere.
About eculizumab
Eculizumab is an antibody that blocks part of the complement system, a set of blood proteins that normally helps fight infection but in some rare diseases attacks the body's own cells. It is used in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
It blocks a protein called C5 and stops the complement cascade from destroying red blood cells and damaging small blood vessels.
An infusion into a vein, weekly to begin with and then every two weeks. Patients must be vaccinated against meningococcal infection before starting, in every market.
Paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, and some forms of myasthenia gravis and neuromyelitis optica.
The diseases are very rare, so comparative studies enrol only a few dozen patients. A biosimilar is compared in the laboratory, in healthy volunteers by measuring complement activity, and in a small study in patients using a blood marker of red cell destruction.
The reference product is Soliris, from Alexion, now part of AstraZeneca. Its price made it a target despite the small number of patients, and the originator has moved many patients to a longer-acting successor.
Eculizumab shows what copying a rare-disease biologic involves: very small trials, a blood marker that regulators accept, and a price high enough to make the work worthwhile for a few hundred patients per country. Only two developers, Amgen and Samsung Bioepis, have done it. There is no Indian or Gulf biosimilar.
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
- Todaytwo eculizumab biosimilars are approved in at least one of the seven markets.
- Further outTUR03 is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from two to three.
2 published switching studies with eculizumab biosimilars, and where evidence is still missing.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Bkemv | Amgen Inc. | May 2024 | 761333 | Interchangeable | Approved | S001, S016 |
| FDA | Epysqli | Samsung Bioepis Co., Ltd. | Jul 2024 | 761340 | Interchangeable | Approved | S001, S016 |
| EMA | Bekemv | Amgen Technology (Ireland) UC | Apr 2023 | EMEA/H/C/005652 | Approved | S017 | |
| EMA | Epysqli | Samsung Bioepis NL B.V. | May 2023 | EMEA/H/C/006036 | Approved | S017 | |
| MHRA | Bekemv | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Epysqli | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| HC | Bekemv | Amgen Canada INC | Apr 2026 | DIN 02540509 | Withdrawn | S022 |
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 eculizumab 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 eculizumab programmes. Regulatory strategy consulting
Presentations and concentration
A single presentation, 300 mg in 30 mL (10 mg/mL) concentrate for infusion.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Bkemv / Bekemv ABP 959 | 300 mg/30 mL vial | see SmPC | 300 mg vial | · | 10 mg | · | · |
| Epysqli SB12 | 300 mg/30 mL vial | see SmPC | 300 mg vial | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Amgen | Bkemv / Bekemv | ✓ | ✓ | ✓ | · | withdrawn | · | · |
| Samsung Bioepis | Epysqli | ✓ | ✓ | ✓ | · | · | · | · |
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
Bkemv / Bekemv
Epysqli
In development
ClinicalTrials.gov holds three comparative trials of two eculizumab biosimilar candidates against the reference product, run by two sponsors. One of the candidates (TUR03) has no approval yet in any of the seven markets, so they show where the next competition may come from. 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 |
|---|---|---|---|---|---|---|---|---|---|
| SB12 | Samsung Bioepis | Soliris | Phase 3 | Comparative efficacy | Completed | Aug 2019 | Sep 2021 | Epysqli | NCT04058158 |
| SB12 | Samsung Bioepis | Soliris | Phase 1 | Comparative PK | Completed | Nov 2018 | Mar 2019 | Epysqli | NCT03722329 |
| TUR03 | Turgut | Soliris | Phase 1 | Comparative PK | Unknown, last recruiting | Apr 2023 | Jul 2024 | no approval in the seven markets | NCT05863442 |
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
Which was the first eculizumab biosimilar?
Amgen's Bekemv in Europe in April 2023, followed by Samsung Bioepis's Epysqli a month later. Both reached the United States in 2024.
Is there an eculizumab biosimilar in India?
No. The only entry in the Indian lists is the originator's own import permission.
Is there an eculizumab biosimilar in the UAE?
No. Soliris is registered.
Are eculizumab biosimilars interchangeable in the United States?
Yes, both. Bkemv from the day of approval and Epysqli from late 2025.
Why are there so few eculizumab biosimilars?
The diseases are very rare, trials are slow, and the originator has shifted patients to a newer product. The economics work only for developers with rare-disease experience.
How is an eculizumab biosimilar tested?
Laboratory comparison, a volunteer study measuring complement activity, and a small study in patients using a blood marker of red cell destruction.
Work with EvySaif on eculizumab
Eculizumab 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 eculizumab, 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) 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 eculizumab biosimilar development?
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