RxBNHerceptin
trastuzumab
1 reference · 6 biosimilar-only
Reference Product
Herceptin
trastuzumab
351(a) Reference Product (Approval Date 10-Feb-2017)
ApplicantGenentech, Inc.
BLA103792
RouteIntravenous
Presentation
Single-Dose Vial
Herceptin
trastuzumab
351(a) Reference Product (Approval Date 10-Feb-2017)
ApplicantGenentech, Inc.
BLA103792
·RouteIntravenous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
No interchangeable biosimilars in this group.
Biosimilars (not interchangeable)
Hercessi
trastuzumab-strf
351(k) Biosimilar (Approval Date 25-Apr-2024)
ApplicantAccord BioPharma Inc.
BLA761346
RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Hercessi
trastuzumab-strf
351(k) Biosimilar (Approval Date 25-Apr-2024)
ApplicantAccord BioPharma Inc.
BLA761346
·RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Herzuma
trastuzumab-pkrb
351(k) Biosimilar (Approval Date 14-Dec-2018)
ApplicantCELLTRION, Inc.
BLA761091
RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Herzuma
trastuzumab-pkrb
351(k) Biosimilar (Approval Date 14-Dec-2018)
ApplicantCELLTRION, Inc.
BLA761091
·RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Kanjinti
trastuzumab-anns
351(k) Biosimilar (Approval Date 13-Jun-2019)
ApplicantAmgen Inc.
BLA761073
RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Kanjinti
trastuzumab-anns
351(k) Biosimilar (Approval Date 13-Jun-2019)
ApplicantAmgen Inc.
BLA761073
·RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Ogivri
trastuzumab-dkst
351(k) Biosimilar (Approval Date 1-Dec-2017)
ApplicantBiocon Biologics Inc.
BLA761074
RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Ogivri
trastuzumab-dkst
351(k) Biosimilar (Approval Date 1-Dec-2017)
ApplicantBiocon Biologics Inc.
BLA761074
·RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Ontruzant
trastuzumab-dttb
351(k) Biosimilar (Approval Date 18-Jan-2019)
ApplicantSamsung Bioepis Co., Ltd.
BLA761100
RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Ontruzant
trastuzumab-dttb
351(k) Biosimilar (Approval Date 18-Jan-2019)
ApplicantSamsung Bioepis Co., Ltd.
BLA761100
·RouteIntravenous
Presentation
Multi-Dose VialSingle-Dose Vial
Trazimera
trastuzumab-qyyp
351(k) Biosimilar (Approval Date 11-Mar-2019)
ApplicantPfizer Ireland Pharmaceuticals Unlimited Company
BLA761081
RouteIntravenous
Presentation
Multi-Dose Vial
Trazimera
trastuzumab-qyyp
351(k) Biosimilar (Approval Date 11-Mar-2019)
ApplicantPfizer Ireland Pharmaceuticals Unlimited Company
BLA761081
·RouteIntravenous
Presentation
Multi-Dose Vial