RxBNLantus
insulin glargine
1 reference · 3 interchangeable
Reference Product
Lantus
insulin glargine
351(a) Reference Product (Approval Date 20-Apr-2000)
ApplicantSanofi-Aventis U.S. LLC
BLA021081
RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial
Lantus
insulin glargine
351(a) Reference Product (Approval Date 20-Apr-2000)
ApplicantSanofi-Aventis U.S. LLC
BLA021081
·RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial
Interchangeable Biosimilars
Langlara
insulin glargine-aldy
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Apr-2026)
ApplicantSunshine Lake Pharma Co., Ltd.
BLA761412
RouteSubcutaneous
Presentation
Autoinjector
Langlara
insulin glargine-aldy
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 29-Apr-2026)
ApplicantSunshine Lake Pharma Co., Ltd.
BLA761412
·RouteSubcutaneous
Presentation
Autoinjector
Rezvoglar
insulin glargine-aglr
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 16-Nov-2022)
ApplicantEli Lilly and Company
BLA761215
RouteSubcutaneous
Presentation
Autoinjector
Rezvoglar
insulin glargine-aglr
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 16-Nov-2022)
ApplicantEli Lilly and Company
BLA761215
·RouteSubcutaneous
Presentation
Autoinjector
Semglee
insulin glargine-yfgn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-Jul-2021)
ApplicantBiocon Biologics Inc.
BLA761201
RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial
Semglee
insulin glargine-yfgn
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 28-Jul-2021)
ApplicantBiocon Biologics Inc.
BLA761201
·RouteSubcutaneous
Presentation
AutoinjectorMulti-Dose Vial
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.