Home/Biosimilar Atlas/Follitropin alfa/Intas follitropin alfa

Intas follitropin alfa

Follitropin alfa biosimilar developed by Intas Pharmaceuticals. Reference product Gonal-f.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Intas Pharmaceuticals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOMay 2013permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Follitropin alfamoleculeIntas Pharmaceuticalsdeveloper1 of 7markets0trials behind it11other products, same developer2rival developers in its markets

About Intas follitropin alfa

Intas received its follitropin alfa permission in India in May 2013, covering anovulation and assisted reproduction.

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
Intas Biopharmaceuticals Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
May 2013
Application or permission
MF-99/2013; BULK-100/2013
Indications as licensed
Anovulation including polycystic ovarian disease; assisted reproduction
Presentations
Injection
Source
S014 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Intas follitropin alfa holds an approval, these are the other follitropin alfa biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Reliance Life Sciences (Reliance Life Sciences follitropin alfa), Zydus Lifesciences (Zydus follitropin alfa)

Same developer, other molecules

Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Pelgraz / Ennumo, Rexatilux / Razumab, Sondelbay / Intas teriparatide.

Chronology

Sources

All follitropin alfa biosimilars

Planning follitropin alfa biosimilar development?

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Data current to September 2026.