FDA Approvals

To view our full FDA Approvals tracking table, click here.

Filgrastim+

NEUPOGEN

#1

#2

#3

Infliximab+

REMICADE

#1

#2

#3

#4

Etanercept+

ENBREL

#1

#2

Adalimumab+

HUMIRA

#1

#2

#3

#4

  • Biosimilar: HADLIMA (adalimumab-bwwd)
  • Applicant: Samsung Bioepis
  • aBLA Approval: July 23, 2019 (50 mg/ml); August 15, 2022 (100 mg/ml)
  • US Launch: TBD
  • Related BPCIA Litigation: None

#5

#6

#7

#8

  • Biosimilar: IDACIO (adalimumab-aacf)
  • Applicant: Fresenius Kabi
  • aBLA Approval: December 14, 2022
  • US Launch: TBD
  • Related BPCIA Litigation: None

Bevacizumab+

AVASTIN

#1

#2

#3

#4

Trastuzumab+

HERCEPTIN

#1

#2

#3

#4

#5

Epoetin Alfa+

EPOGEN/ PROCRIT

#1

Pegfilgrastim+

NEULASTA

#1

#2

#3

#4

#5

  • Biosimilar: FYLNETRA (pegfilgrastim-pbbk)
  • Applicant: Amneal/Kashiv
  • aBLA Approval: May 27, 2022
  • US Launch: TBD
  • Related BPCIA Litigation: None

#6

  • Biosimilar: STIMUFEND (pegfilgrastim-fpgk)
  • Applicant: Fresenius Kabi
  • aBLA Approval: Sept. 1, 2022
  • US Launch: TBD
  • Related BPCIA Litigation: None

Rituximab+

RITUXAN

#1

#2

#3

  • Biosimilar: RIABNI (rituximab-arrx)
  • Applicant: Amgen
  • aBLA Approval: Dec. 17, 2020
  • US Launch: Jan. 12, 2021
  • Related BPCIA Litigation: None

Insulin Glargine+

LANTUS

#1

  • Biosimilar: SEMGLEE (insulin glargine-yfgn)
  • Applicant: Viatris
  • aBLA Approval: July 28, 2021
  • US Launch: November 16, 2021
  • Related BPCIA Litigation: None

#2

Ranibizumab+

LUCENTIS

#1

  • Biosimilar: BYOOVIZ (ranibizumab-nuna)
  • Applicant: Biogen/ Samsung Bioepis
  • aBLA Approval: Sep. 20, 2021
  • US Launch: June 2, 2022
  • Related BPCIA Litigation: None

#2

Last updated: December 14, 2022