Test 2 – FDA Approvals

Filgrastim+

  • Biosimilar: RELEUKO (filgrastim-ayow)
  • Applicant: Amneal/Kashiv
  • Reference Product: NEUPOGEN [#3]
  • aBLA Approval: March 1, 2022
  • US Launch:
  • Related BPCIA Litigation: None

Infliximab+

  • Biosimilar: IXIFI (infliximab-qbtx)
  • Applicant: Pfizer
  • Reference Product: REMICADE [#3]
  • aBLA Approval: Dec. 13, 2017
  • US Launch:
  • Related BPCIA Litigation: None
  • Biosimilar: AVSOLA (infliximab-axxq)
  • Applicant: Amgen
  • Reference Product: REMICADE [#4]
  • aBLA Approval: Dec. 6, 2019
  • US Launch: July 2020
  • Related BPCIA Litigation: None

Etanercept+

Adalimumab+

  • Biosimilar: HADLIMA (adalimumab-bwwd)
  • Applicant: Samsung Bioepis
  • Reference Product: HUMIRA [#4]
  • aBLA Approval: July 23, 2019
  • US Launch:
  • Related BPCIA Litigation: None
  • Biosimilar: ABRILADA (adalimumab-afzb)
  • Applicant: Pfizer
  • Reference Product: HUMIRA [#5]
  • aBLA Approval: Nov. 15, 2019
  • US Launch:
  • Related BPCIA Litigation: None
  • Biosimilar: HULIO (adalimumab-fkjp)
  • Applicant: Mylan
  • Reference Product: HUMIRA [#6]
  • aBLA Approval: July 6, 2020
  • US Launch:
  • Related BPCIA Litigation: None
  • Biosimilar: YUSIMRY (adalimumab-aqvh)
  • Applicant: Coherus
  • Reference Product: HUMIRA [#7]
  • aBLA Approval: Dec. 20, 2021
  • US Launch:
  • Related BPCIA Litigation: None

Bevacizumab+

  • Biosimilar: ALYMSYS (bevacizumab-maly)
  • Applicant: Amneal/mAbxience
  • Reference Product: AVASTIN (#3)
  • aBLA Approval: April 13, 2022
  • US Launch:
  • Related BPCIA Litigation: None

Trastuzumab+

Epoetin Alfa+

Pegfilgrastim+

  • Biosimilar: FYLNETRA (pegfilgrastim-pbbk)
  • Applicant: Amneal/Kashiv
  • Reference Product: NEULASTA (#5)
  • aBLA Approval: May 27, 2022
  • US Launch:
  • Related BPCIA Litigation: None

Rituximab+

  • Biosimilar: RIABNI (rituximab-arrx)
  • Applicant: Amgen
  • Reference Product: RITUXAN [#3]
  • aBLA Approval: Dec. 17, 2020
  • US Launch: Jan. 12, 2021
  • Related BPCIA Litigation: None

Insulin Glargine+

  • Biosimilar: SEMGLEE (insulin glargine-yfgn)
  • Applicant: Viatris
  • Reference Product: LANTUS (#1)
  • aBLA Approval: July 28, 2021
  • US Launch: November 16, 2021
  • Related BPCIA Litigation: None
  • Biosimilar: REZVOGLAR (insulin glargine-aglr)
  • Applicant: Eli Lilly
  • Reference Product: LANTUS (#2)
  • aBLA Approval: Dec. 20, 2021
  • US Launch:
  • Related BPCIA Litigation: None

Ranibizumab+

  • Biosimilar: BYOOVIZ (ranibizumab-nuna)
  • Applicant: Biogen/ Samsung Bioepis
  • Reference Product: LUCENTIS (#1)
  • aBLA Approval: Sep. 20, 2021
  • US Launch:
  • Related BPCIA Litigation: None
  • Biosimilar: CIMERLI (ranibizumab-eqrn)
  • Applicant: Coherus
  • Reference Product: LUCENTIS (#2)
  • aBLA Approval: August 2, 2022
  • US Launch:
  • Related BPCIA Litigation:

Last updated: August 4, 2022