Fulphila / Vivlipeg / Biopegfil
Pegfilgrastim biosimilar developed by Biocon Biologics (with Mylan / Viatris), development code MYL-1401H. Reference product Neulasta.
Brands by market: Fulphila (USA, EU, UAE); Vivlipeg (EU); Biopegfil (UAE) · Commercial partner or holder: Biocon Biologics
FDAJun 2018approved
EMANov 2018authorised
CDSCOnot listed
EDEFeb 2019registered
Status by market
FDA
United States · Fulphila
US Food and Drug AdministrationApprovedBrand
Fulphila
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Jun 2018
Application or permission
761075
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
Note
First FDA-approved pegfilgrastim biosimilar.
Source
S001, S016
EMA
European Union · Fulphila
European Medicines Agency and European CommissionApprovedBrand
Fulphila
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Nov 2018
Application or permission
EMEA/H/C/004915
Indications as licensed
Neutropenia in cytotoxic chemotherapy
Presentations
see SmPC
Source
S017
EMA
European Union · Vivlipeg
European Medicines Agency and European CommissionApprovedBrand
Vivlipeg
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Aug 2025
Application or permission
EMEA/H/C/006739
Presentations
see SmPC
Note
Second Biocon brand.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates · Biopegfil
Emirates Drug EstablishmentRegisteredBrand
Biopegfil
Holder or applicant
Biocon Biologics Limited, India · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Feb 2019
Presentations
6 mg/0.6 mL
Source
S018
EDE
United Arab Emirates · Fulphila
Emirates Drug EstablishmentRegisteredBrand
Fulphila
Holder or applicant
Biocon Biologics Limited, India (country of origin Ireland) · UAE supplier Lunatus Drug Store LLC
Pathway
Registered medical product
Registered
Nov 2019
Presentations
6 mg/0.6 mL
Source
S018
Chronology
- FDAJun 2018Approved by FDA as Fulphila
- EMANov 2018Authorised by the European Commission as Fulphila
- EDEFeb 2019Registered in the UAE as Biopegfil
- EDENov 2019Registered in the UAE as Fulphila
- EMAAug 2025Authorised by the European Commission as Vivlipeg
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)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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