Home/Biosimilar Atlas/Eculizumab/Bkemv / Bekemv

Bkemv / Bekemv

Eculizumab biosimilar developed by Amgen, development code ABP 959. Reference product Soliris.

Brands by market: Bkemv (USA); Bekemv (EU) · Commercial partner or holder: Amgen · Company profile

FDAMay 2024approved

EMAApr 2023authorised

MHRALicenseddate not shown

PMDANot listed

HCWithdrawn

CDSCONot listed

EDENot listed

Approved or registered in 3 of 7 markets

Connections

Eculizumabmolecule Amgendeveloper 3 of 7markets 0trials behind it 7other products, same developer 1rival developers in its markets

About Bkemv / Bekemv

Bekemv is Amgen's eculizumab, the first eculizumab biosimilar approved in Europe, in April 2023. In the United States it is spelled Bkemv, approved in May 2024 and interchangeable from the start. A Canadian approval was cancelled before the product was marketed there.

Status by market

FDA

United States · Bkemv

US Food and Drug AdministrationApproved

Brand

Bkemv

Holder or applicant

Amgen Inc.

Pathway

351(k)

Approved

May 2024

Application or permission

761333

Licence type

351(k) interchangeable, designated May 2024

Reference product in the Purple Book

Soliris

Marketing status (Purple Book)

Prescription, marketed

First-interchangeable exclusivity expiry

Nov 2025

Presentations

300 mg/30 mL vial

Remarks

First eculizumab biosimilar in the United States; interchangeable on licensure.

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union · Bekemv

European Medicines Agency and European CommissionApproved

Brand

Bekemv

Holder or applicant

Amgen Technology (Ireland) UC

Pathway

Centralised (Article 10(4))

Approved

Apr 2023

Application or permission

EMEA/H/C/005652

Indications as licensed

PNH, aHUS

Presentations

see SmPC

Remarks

First EU eculizumab biosimilar.

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Bekemv

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Bekemv

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

300 mg vial

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada · Bekemv

Health CanadaWithdrawn

Brand

Bekemv

Holder or applicant

Amgen Canada INC

Pathway

Biosimilar biologic drug (Notice of Compliance)

Approved

Apr 2026

Application or permission

DIN 02540509

Withdrawn

date not published

Presentations

10 mg

Remarks

Cancelled before marketing in the Drug Product Database.

Source

S022 (Health Canada) · checked Sep 2026

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Bkemv / Bekemv holds an approval, these are the other eculizumab biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	1	Samsung Bioepis (Epysqli)
EMA	1	Samsung Bioepis (Epysqli)
MHRA	1	Samsung Bioepis (Epysqli)

Same developer, other molecules

Other biosimilars in the Atlas developed by Amgen: Amjevita / Amgevita, Avsola, Kanjinti, Mvasi, Pavblu, Riabni, Wezlana / Wezenla.

Chronology

EMAApr 2023Authorised by the European Commission as Bekemv
FDAMay 2024Approved by FDA as Bkemv

Sources

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)

All eculizumab biosimilars

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Data current to September 2026.