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
FDADec 2017approved
EMADec 2018authorised
CDSCOOct 2013permitted
EDENov 2018registered
Status by market
FDA
United States · Ogivri
US Food and Drug AdministrationApprovedBrand
Ogivri
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Dec 2017
Application or permission
761074
Licence type
351(k) biosimilar, not interchangeable
Presentations
150 mg, 420 mg vials
Note
First FDA-approved trastuzumab biosimilar.
Source
S001, S016
EMA
European Union · Ogivri
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India · CANMAb
Central Drugs Standard Control OrganisationApprovedBrand
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
Note
First trastuzumab biosimilar approved anywhere.
Source
S014
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
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
Note
New presentation of the 2013 product.
Source
S011
EDE
United Arab Emirates · Ogivri
Emirates Drug EstablishmentRegisteredBrand
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
Chronology
- CDSCOOct 2013CDSCO permission granted as CANMAb
- FDADec 2017Approved by FDA as Ogivri
- EDENov 2018Registered in the UAE as Ogivri
- EMADec 2018Authorised by the European Commission as Ogivri
- CDSCONov 2025CDSCO permission granted
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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