Home/Biosimilar Atlas/Trastuzumab/Ogivri / CANMAb

Ogivri / CANMAb

Trastuzumab biosimilar developed by Biocon Biologics (with Mylan / Viatris), development code MYL-1401O (Bmab-200). Reference product Herceptin.

Brands by market: Ogivri (USA, EU, UAE); CANMAb (India) · Commercial partner or holder: Biocon Biologics · Company profile
FDADec 2017approved
EMADec 2018authorised
MHRALicenseddate not shown
PMDANot listed
HCMay 2019approved
CDSCOOct 2013permitted
EDENov 2018registered
Approved or registered in 6 of 7 markets
Connections
TrastuzumabmoleculeBiocon Biologicsdeveloper6 of 7markets0trials behind it8other products, same developer12rival developers in its markets

About Ogivri / CANMAb

Ogivri is the first trastuzumab biosimilar in the world. Biocon's product was permitted in India in October 2013, sold there as CANMAb, four years before any Western approval. It became the first trastuzumab biosimilar approved in the United States in December 2017, then in Europe in 2018, and is registered in the UAE and Canada. It was originally marketed with Mylan and now sits with Biocon Biologics. In 2025 Biocon received a new Indian permission for a combination pack of the product with its diluent.

Status by market

FDA

United States · Ogivri

US Food and Drug AdministrationApproved
Brand
Ogivri
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Dec 2017
Application or permission
761074
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Herceptin
Marketing status (Purple Book)
Prescription, marketed
Presentations
150 mg, 420 mg vials
Remarks
First FDA-approved trastuzumab biosimilar.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Ogivri

European Medicines Agency and European CommissionApproved
Brand
Ogivri
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Dec 2018
Application or permission
EMEA/H/C/004916
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Ogivri

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Ogivri
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
150 mg and 420 mg vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Ogivri

Health CanadaApproved
Brand
Ogivri
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
May 2019
Application or permission
DIN 02474425, 02474433
Presentations
150, 440 mg
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India · CANMAb

Central Drugs Standard Control OrganisationApproved
Brand
CANMAb
Holder or applicant
Biocon Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2013
Application or permission
MF-241/2013; BULK-242/2013
Indications as licensed
HER2-positive metastatic breast cancer
Presentations
150 mg single-use and 440 mg multi-use vials
Remarks
First trastuzumab biosimilar approved anywhere.
Source
S014 (CDSCO) · checked Sep 2026
CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Biocon Biologics Limited
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Nov 2025
Application or permission
MF/BIO/25/000156
Indications as licensed
Adjuvant and metastatic breast cancer, metastatic gastric cancer
Presentations
150 mg and 440 mg multi-use vials, combipack with bacteriostatic water
Remarks
New presentation of the 2013 product.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates · Ogivri

Emirates Drug EstablishmentRegistered
Brand
Ogivri
Holder or applicant
Biocon Biologics Limited, India · UAE supplier Lunatus Drug Store LLC
Pathway
Registered medical product
Registered
Nov 2018
Presentations
440 mg vial
Source
S018 (UAE Emirates Drug Establishment) · checked Sep 2026

Other developers in the same markets

Where Ogivri / CANMAb holds an approval, these are the other trastuzumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA5Amgen (Kanjinti), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
EMA7Amgen (Kanjinti), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
MHRA5Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac)
HC4Amgen (Kanjinti), Celltrion (Herzuma), Pfizer (Trazimera), Samsung Bioepis (Ontruzant)
CDSCO6Biocad (Biocad trastuzumab), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Dr. Reddy's Laboratories (Dr. Reddy's trastuzumab), Intas Pharmaceuticals (Intas trastuzumab), Reliance Life Sciences (Reliance Life Sciences trastuzumab), Zydus Lifesciences (Zydus trastuzumab)
EDE3Amgen (Kanjinti), Celltrion (Herzuma), Pfizer (Trazimera)

Same developer, other molecules

Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Semglee, Yesafili, Yesintek / Usrenty.

Chronology

Sources

All trastuzumab biosimilars

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Data current to September 2026.