Bioviz epoetin
Epoetin alfa and zeta biosimilar developed by Bioviz Technologies. Reference product Eprex (Epogen and Procrit in the United States).
Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Bioviz Technologies · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOAug 2011permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Bioviz epoetin
Bioviz received its epoetin permission in India in August 2011, in pre-filled syringes for kidney patients. Bioviz is a Hyderabad biologics company that had earlier imported filgrastim.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Bioviz Technologies Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Aug 2011
Application or permission
MF-333/11
Indications as licensed
Anaemia of renal insufficiency, in haemodialysis and non-dialysis patients
Presentations
2,000 and 4,000 IU/mL PFS
Source
S014 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Bioviz epoetin holds an approval, these are the other epoetin alfa and zeta biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 3 | Not stated in the CDSCO list (Cipla epoetin), Wockhardt (Wockhardt epoetin), Zydus Lifesciences (Zydus epoetin) |
Chronology
- CDSCOAug 2011CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
Planning epoetin alfa and zeta biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.