Home/Biosimilar Atlas/Pegfilgrastim/Gennova pegfilgrastim

Gennova pegfilgrastim

Pegfilgrastim biosimilar developed by Gennova Biopharmaceuticals (Emcure). Reference product Neulasta.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Gennova Biopharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJan 2010permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Gennova pegfilgrastim

Gennova, part of Emcure, holds the first pegfilgrastim permission in the published Indian lists, from January 2010, and one of the first anywhere in the world. Gennova also received a filgrastim permission that year.

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
Gennova Biopharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jan 2010
Application or permission
MF-104/10
Indications as licensed
Prevention of neutropenia in patients receiving cancer chemotherapy
Presentations
6 mg/0.6 mL PFS
Remarks
First pegfilgrastim biosimilar in the published CDSCO lists.
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Gennova pegfilgrastim holds an approval, these are the other pegfilgrastim biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO5Dr. Reddy's Laboratories (Dr. Reddy's pegfilgrastim), Lupin (Armlupeg / Lupin pegfilgrastim), USV (USV pegfilgrastim), Virchow Biotech (Virchow Biotech pegfilgrastim), Wockhardt (Wockhardt pegfilgrastim)

Same developer, other molecules

Other biosimilars in the Atlas developed by Gennova Biopharmaceuticals: Gennova filgrastim.

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.