FDA Approvals

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

Adalimumab+

HUMIRA

#1

#2

#3

#4

#5

#6

#7

#8

  • Biosimilar: IDACIO (adalimumab-aacf)
  • Applicant: Fresenius Kabi
  • BLA Approval: December 14, 2022
  • US Launch: July 3, 2023
  • Related BPCIA Litigation: None

#9

  • Biosimilar: YUFLYMA (adalimumab-aaty)
  • Applicant: Celltrion
  • BLA Approval: May 24, 2023 (40 mg/0.4 mL); Oct. 2, 2023 (80 mg/0.8 mL, and 20 mg/0.2 mL)
  • US Launch: July 2, 2023
  • Related BPCIA Litigation: None

#10

  • Biosimilar: SIMLANDI (adalimumab-ryvk)
  • Applicant: Alvotech
  • BLA Approval: February 23, 2024.  First interchangeable biosimilar to HUMIRA
  • US Launch:  May 20, 2024
  • Related BPCIA Litigation: AbbVie v. Alvotech

Aflibercept+

EYLEA

#1

  • Biosimilar: YESAFILI (aflibercept-jbvf)
  • Applicant: Biocon Biologics
  • BLA Approval: May 20, 2024 (2 mg: 0.05 ml of 40 mg/mL, interchangeable)
  • US Launch: TBD
  • Related BPCIA Litigation: Regeneron v. Mylan

#2

Bevacizumab+

AVASTIN

#1

#2

#3

#4

#5

  • Biosimilar: AVZIVI (bevacizumab-tnjn)
  • Applicant: Bio-Thera Solutions, Ltd.
  • BLA Approval: Dec. 7, 2023
  • US Launch: N/A
  • Related BPCIA Litigation: None

Denosumab+

PROLIA

#1

  • Biosimilar: JUBBONTI (denosumab-bddz)
  • Applicant: Sandoz
  • BLA Approval: March 5, 2024
  • US Launch: N/A
  • Related BPCIA Litigation: Amgen v. Sandoz, 2:23-CV-02406 (D. N.J.)

XGEVA

#1

  • Biosimilar: WYOST (denosumab-bddz)
  • Applicant: Sandoz
  • BLA Approval: March 5, 2024
  • US Launch: N/A
  • Related BPCIA Litigation: Amgen v. Sandoz, 2:23-CV-02406 (D. N.J.)

Epoetin Alfa+

EPOGEN/ PROCRIT

#1

Etanercept+

ENBREL

#1

#2

Filgrastim+

NEUPOGEN

#1

#2

#3

Infliximab+

REMICADE

#1

#2

#3

#4

#5

  • Biosimilar: ZYMFENTRA (infliximab-dyyb) (subcutaneous)
  • Applicant: Celltrion
  • BLA Approval: Oct. 23, 2023
  • US Launch: March 18, 2024
  • Related BPCIA Litigation: None

Insulin Glargine+

LANTUS

#1

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

#2

Natalizumab+

TYSABRI

#1

Pegfilgrastim+

NEULASTA

#1

#2

#3

#4

#5

#6

  • Biosimilar: STIMUFEND (pegfilgrastim-fpgk)
  • Applicant: Fresenius Kabi
  • BLA Approval: Sept. 1, 2022
  • US Launch: February 16, 2023
  • Related BPCIA Litigation: None

Ranibizumab+

LUCENTIS

#1

  • Biosimilar: BYOOVIZ (ranibizumab-nuna)
  • Applicant: Biogen/ Samsung Bioepis
  • BLA Approval: Sep. 20, 2021; Oct. 3, 2023 (interchangeable designation)
  • US Launch: June 2, 2022
  • Related BPCIA Litigation: None

#2

Rituximab+

RITUXAN

#1

#2

#3

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

Tocilizumab+

ACTEMRA

#1

#2

Trastuzumab+

HERCEPTIN

#1

#2

#3

#4

#5

#6

Ustekinumab+

STELARA

#1

  • Biosimilar: WEZLANA (ustekinumab-auub)
  • Applicant: Amgen
  • BLA Approval: Oct. 31, 2023
  • US Launch: N/A
  • Related BPCIA Litigation: Janssen Biotech v. Amgen, 1:22-CV-1549 (D. Del.)

#2

Last updated:  May 21, 2024