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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) · Commercial partner or holder: Zydus Lifesciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2011permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Interferon alfa-2bmoleculeCadila Healthcaredeveloper1 of 7markets0trials behind it10other products, same developer2rival developers in its markets

About Zydus peginterferon alfa-2b

Zydus, then Cadila Healthcare, received the first permission in the world for a pegylated interferon alfa-2b biosimilar, in India in June 2011, for hepatitis B and C. In April 2021 it was given a restricted emergency use in COVID-19, giving the product a second life after antiviral tablets replaced interferon in hepatitis C.

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 OrganisationApproved
Brand
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
Remarks
First pegylated interferon biosimilar permitted anywhere.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Zydus peginterferon alfa-2b holds an approval, these are the other interferon alfa-2b biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Intas Pharmaceuticals (Intas peginterferon alfa-2b), Not stated in the CDSCO list (USV interferon alfa-2b)

Same developer, other molecules

Other biosimilars in the Atlas developed by Zydus Lifesciences: Exemptia / Cadalimab, Nufymco, Zydus aflibercept, Zydus bevacizumab, Zydus epoetin, Zydus follitropin alfa, Zydus pertuzumab, Zydus rituximab, Zydus teriparatide, Zydus trastuzumab.

Chronology

Sources

All interferon alfa-2b biosimilars

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Data current to September 2026.