RxBNXolair
omalizumab
1 reference · 1 interchangeable
Reference Product
Xolair
omalizumab
351(a) Reference Product (Approval Date 20-Jun-2003)
ApplicantGenentech, Inc.
BLA103976
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Xolair
omalizumab
351(a) Reference Product (Approval Date 20-Jun-2003)
ApplicantGenentech, Inc.
BLA103976
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled SyringeSingle-Dose Vial
Interchangeable Biosimilars
Omlyclo
omalizumab-igec
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 7-Mar-2025)
ApplicantCELLTRION, Inc.
BLA761399
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Omlyclo
omalizumab-igec
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 7-Mar-2025)
ApplicantCELLTRION, Inc.
BLA761399
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.