USV interferon alfa-2b
Interferon alfa-2b biosimilar developed by Not stated in the CDSCO list. Reference product Intron A and PegIntron (Merck).
Brands by market: Brand not published by CDSCO (India, import) ยท Commercial partner or holder: USV (import)
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOSep 2009permitted
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
USV Ltd
Pathway
Import and marketing permission
Approved
Sep 2009
Application or permission
Import permission
Indications as licensed
Chronic hepatitis B and C
Presentations
3 and 5 million IU lyophilised vials
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOSep 2009CDSCO permission granted
Sources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
Planning interferon alfa-2b 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.