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 · Company profile
FDAJun 2018approved
EMANov 2018authorised
MHRALicenseddate not shown
PMDANot listed
HCDec 2018approved
CDSCONot listed
EDEFeb 2019registered
Approved or registered in 5 of 7 markets
Connections
About Fulphila / Vivlipeg / Biopegfil
Fulphila is Biocon's pegfilgrastim, the first pegfilgrastim biosimilar approved in the United States, in June 2018, and approved in Europe and Canada later that year. In the UAE it is registered twice, as Fulphila from the Irish licence and as Biopegfil direct from India. Biocon added a second European name, Vivlipeg, in 2025. It was originally marketed with Mylan and now sits with Biocon Biologics.
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
Reference product in the Purple Book
Neulasta
Marketing status (Purple Book)
Prescription, marketed
Presentations
6 mg/0.6 mL PFS
Remarks
First FDA-approved pegfilgrastim biosimilar.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Second Biocon brand.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Fulphila
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Fulphila
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
6 mg syringe
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada · Fulphila
Health CanadaApprovedBrand
Fulphila
Holder or applicant
Biocon Biologics Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Dec 2018
Application or permission
DIN 02484153
Presentations
10 mg
Source
S022 (Health Canada) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Fulphila / Vivlipeg / Biopegfil holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 7 | Coherus BioSciences (Udenyca), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| EMA | 7 | Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| MHRA | 5 | Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Sandoz (Ziextenzo) |
| HC | 4 | Intas Pharmaceuticals (Pelgraz / Ennumo), Nora Pharma (Niopeg), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| EDE | 3 | Intas Pharmaceuticals (Pelgraz / Ennumo), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Semglee, Yesafili, Yesintek / Usrenty.
Chronology
- FDAJun 2018Approved by FDA as Fulphila
- EMANov 2018Authorised by the European Commission as Fulphila
- HCDec 2018Notice of Compliance, Health Canada 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)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)
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