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
FDAMay 2024approved
EMAApr 2023authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Bkemv
US Food and Drug AdministrationApprovedBrand
Bkemv
Holder or applicant
Amgen Inc.
Pathway
351(k)
Approved
May 2024
Application or permission
761333
Licence type
351(k) interchangeable, designated May 2024
Presentations
300 mg/30 mL vial
Note
First eculizumab biosimilar in the United States; interchangeable on licensure.
Source
S001, S016
EMA
European Union · Bekemv
European Medicines Agency and European CommissionApprovedBrand
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
Note
First EU eculizumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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