Zydus peginterferon alfa-2b
Interferon alfa-2b biosimilar developed by Cadila Healthcare (Zydus Lifesciences). Reference product Intron A and PegIntron (Merck).
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Zydus Lifesciences
FDAnot listed
EMAnot listed
PMDAnot listed
HCnot listed
CDSCOJun 2011permitted
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
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2011
Application or permission
MF-266/11; additional indication 23 April 2021 (restricted emergency use in COVID-19)
Indications as licensed
Chronic hepatitis B and C with ribavirin; restricted emergency use in COVID-19 added April 2021
Presentations
Lyophilised peginterferon alfa-2b for subcutaneous injection
Note
First pegylated interferon biosimilar permitted anywhere.
Source
S014
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2011CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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