RxBNRemicade
infliximab
1 reference · 3 biosimilar-only
Reference Product
Remicade
infliximab
351(a) Reference Product (Approval Date 24-Aug-1998)
ApplicantJanssen Biotech, Inc.
BLA103772
RouteIntravenous
Presentation
Single-Dose Vial
Remicade
infliximab
351(a) Reference Product (Approval Date 24-Aug-1998)
ApplicantJanssen Biotech, Inc.
BLA103772
·RouteIntravenous
Presentation
Single-Dose Vial
Interchangeable Biosimilars
No interchangeable biosimilars in this group.
Biosimilars (not interchangeable)
Avsola
infliximab-axxq
351(k) Biosimilar (Approval Date 6-Dec-2019)
ApplicantAmgen Inc.
BLA761086
RouteIntravenous
Presentation
Single-Dose Vial
Avsola
infliximab-axxq
351(k) Biosimilar (Approval Date 6-Dec-2019)
ApplicantAmgen Inc.
BLA761086
·RouteIntravenous
Presentation
Single-Dose Vial
Inflectra
infliximab-dyyb
351(k) Biosimilar (Approval Date 5-Apr-2016)
ApplicantCELLTRION, Inc.
BLA125544
RouteIntravenous
Presentation
Single-Dose Vial
Inflectra
infliximab-dyyb
351(k) Biosimilar (Approval Date 5-Apr-2016)
ApplicantCELLTRION, Inc.
BLA125544
·RouteIntravenous
Presentation
Single-Dose Vial
Renflexis
infliximab-abda
351(k) Biosimilar (Approval Date 21-Apr-2017)
ApplicantSamsung Bioepis Co., Ltd.
BLA761054
RouteIntravenous
Presentation
Single-Dose Vial
Renflexis
infliximab-abda
351(k) Biosimilar (Approval Date 21-Apr-2017)
ApplicantSamsung Bioepis Co., Ltd.
BLA761054
·RouteIntravenous
Presentation
Single-Dose Vial