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Adalimumab+
HUMIRA
#1
- Biosimilar: AMJEVITA (adalimumab-atto)
- Applicant: Amgen
- BLA Approval: Sept. 23, 2016
- US Launch: January 31, 2023
- Related BPCIA Litigation: AbbVie v. Amgen
#2
- Biosimilar: CYLTEZO (adalimumab-adbm)
- Applicant: Boehringer Ingelheim
- BLA Approval: Aug. 25, 2017 (40 mg/0.8 mL single-use prefilled syringe; Oct. 18, 2021 (interchangeable status); May 22, 2023 (40 mg/0.8 mL autoinjector, 20 mg/0.4 mL and 10 mg/0.2 mL single-use prefilled syringe); April 30, 2024 (40 mg/0.4 mL autoinjector and single-use prefilled glass syringe)
- US Launch: July 1, 2023
- Related BPCIA Litigation: AbbVie v. BI
#3
- Biosimilar: HYRIMOZ (adalimumab-adaz)
- Applicant: Sandoz
- BLA Approval: Oct. 30, 2018 (50 mg/ml); March 21, 2023 (100 mg/ml)
- US Launch: July 1, 2023
- Related BPCIA Litigation: AbbVie v. Sandoz
#4
- Biosimilar: HADLIMA (adalimumab-bwwd)
- Applicant: Samsung Bioepis
- BLA Approval: July 23, 2019 (50 mg/ml); August 15, 2022 (100 mg/ml)
- US Launch: July 1, 2023
- Related BPCIA Litigation: None
#5
- Biosimilar: ABRILADA (adalimumab-afzb)
- Applicant: Pfizer
- BLA Approval: Nov. 15, 2019; Oct. 5, 2023 (interchangeable status)
- US Launch: October 2023
- Related BPCIA Litigation: None
#6
- Biosimilar: HULIO (adalimumab-fkjp)
- Applicant: Mylan
- BLA Approval: July 6, 2020
- US Launch: July 3, 2023
- Related BPCIA Litigation: None
#7
- Biosimilar: YUSIMRY (adalimumab-aqvh)
- Applicant: Coherus
- BLA Approval: Dec. 20, 2021
- US Launch: July 1, 2023
- Related BPCIA Litigation: None
#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 (40 mg/0.4 mL, interchangeable).
- 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
- Biosimilar: OPUVIZ (aflibercept-yszy)
- Applicant: Samsung Bioepis Co. Ltd.
- BLA Approval: May 20, 2024 (2 mg: 0.05 ml of 40 mg/mL, interchangeable)
- US Launch: TBD
- Related BPCIA Litigation: Regeneron v. Samsung Bioepis
#3
- Biosimilar: FYB203/AHZANTIVE (aflibercept-mrbb)
- Applicant: Formycon
- BLA Approval: July 1, 2024
- US Launch: TBD
- Related BPCIA Litigation: Regeneron v. Formycon
#4
- Biosimilar: ENZEEVU (aflibercept-abzv)
- Applicant: Sandoz
- BLA Approval: August 9, 2024
- US Launch: TBD
- Related BPCIA Litigation: Regeneron v. Sandoz
#5
- Biosimilar: PAVBLU (aflibercept-ayyh)
- Applicant: Amgen
- BLA Approval: August 23, 2024
- US Launch: October 30, 2024
- Related BPCIA Litigation: Regeneron v. Amgen
Bevacizumab+
AVASTIN
#1
- Biosimilar: MVASI (bevacizumab-awwb)
- Applicant: Amgen
- BLA Approval: Sept. 14, 2017
- US Launch: July 19, 2019
- Related BPCIA Litigation: Genentech v. Amgen
#2
- Biosimilar: ZIRABEV (bevacizumab-bvzr)
- Applicant: Pfizer
- aBLA Approval: June 28, 2019
- US Launch: Dec. 31, 2019
- Related BPCIA Litigation: Genentech v. Pfizer
#3
- Biosimilar: ALYMSYS (bevacizumab-maly)
- Applicant: Amneal/mAbxience
- BLA Approval: April 13, 2022
- US Launch: Oct. 3, 2022
- Related BPCIA Litigation: None
#4
- Biosimilar: VEGZELMA (bevacizumab-adcd)
- Applicant: Celltrion
- BLA Approval: Sept. 27, 2022
- US Launch: April 17, 2023
- Related BPCIA Litigation: None
#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.)
Eculizumab+
SOLIRIS
#1
- Biosimilar: BKEMV (eculizumab-aeeb)
- Applicant: Amgen
- BLA Approval: May 28, 2024 (interchangeable)
- US Launch: N/A
- Related BPCIA Litigation: N/A
#2
- Biosimilar: EPYSQLI (eculizumab-aagh)
- Applicant: Samsung Bioepis
- BLA Approval: July 22, 2024
- US Launch: N/A
- Related BPCIA Litigation: Alexion Pharmaceuticals, Inc. et al. v. Samsung Bioepis Co. Ltd., 1-24-cv-00005 (D. Del.)
Epoetin Alfa+
EPOGEN/ PROCRIT
#1
- Biosimilar: RETACRIT (epoetin alfa-epbx)
- Applicant: Hospira
- BLA Approval: May 15, 2018
- US Launch: Nov. 12, 2018
- Related BPCIA Litigation: Amgen v. Hospira
Etanercept+
ENBREL
#1
- Biosimilar: ERELZI (etanercept-szzs)
- Applicant: Sandoz
- BLA Approval: Aug. 30, 2016
- US Launch: TBD
- Related BPCIA Litigation: Immunex v. Sandoz
#2
- Biosimilar: ETICOVO (etanercept-ykro)
- Applicant: Samsung Bioepis
- BLA Approval: Apr. 25, 2019
- US Launch: TBD
- Related BPCIA Litigation: Immunex v. Samsung Bioepis
Filgrastim+
NEUPOGEN
#1
- Biosimilar: ZARXIO (filgrastim-sndz)
- Applicant: Sandoz
- BLA Approval: Mar. 6, 2015
- US Launch: Sept. 3, 2015
- Related BPCIA Litigation: Amgen v. Sandoz
#2
- Biosimilar: NIVESTYM (filgrastim-aafi)
- Applicant: Pfizer
- BLA Approval: July 20, 2018
- US Launch: Oct. 1, 2018
- Related BPCIA Litigation: Amgen v. Hospira
#3
- Biosimilar: RELEUKO (filgrastim-ayow)
- Applicant: Amneal/Kashiv
- BLA Approval: Mar. 1, 2022
- US Launch: Nov. 22, 2022
- Related BPCIA Litigation: None
#4
- Biosimilar: NYPOZI (TX-01) (filgrastim-txid)
- Applicant: Tanvex BioPharma USA, Inc.
- BLA Approval: June 28, 2024
- US Launch: N/A
- Related BPCIA Litigation: None
Infliximab+
REMICADE
#1
- Biosimilar: INFLECTRA (infliximab-dyyb)
- Applicant: Celltrion
- BLA Approval: Apr. 5, 2016
- US Launch: Nov. 21, 2016
- Related BPCIA Litigation: Janssen v. Celltrion
#2
- Biosimilar: RENFLEXIS (infliximab-abda)
- Applicant: Samsung Bioepis
- BLA Approval: Apr. 21, 2017
- US Launch: July 24, 2017
- Related BPCIA Litigation: Janssen v. Samsung Bioepis
#3
- Biosimilar: IXIFI (infliximab-qbtx)
- Applicant: Pfizer
- BLA Approval: Dec. 13, 2017
- US Launch: TBD
- Related BPCIA Litigation: None
#4
- Biosimilar: AVSOLA (infliximab-axxq)
- Applicant: Amgen
- BLA Approval: Dec. 6, 2019
- US Launch: July 2020
- Related BPCIA Litigation: None
#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
- Biosimilar: REZVOGLAR (insulin glargine-aglr)
- Applicant: Eli Lilly
- BLA Approval: Dec. 20, 2021 (original approval); Nov. 16, 2022 (approved as an interchangeable)
- US Launch: April 1, 2023
- Related BPCIA Litigation: None
Natalizumab+
TYSABRI
#1
- Biosimilar: TYRUKO (natalizumab-sztn)
- Applicant: Sandoz
- BLA Approval: August 24, 2023
- US Launch: N/A
- Related BPCIA Litigation: Biogen v. Sandoz
Pegfilgrastim+
NEULASTA
#1
- Biosimilar: FULPHILA (pegfilgrastim-jmdb)
- Applicant: Mylan
- BLA Approval: June 4, 2018
- US Launch: July 26, 2018
- Related BPCIA Litigation: Amgen v. Mylan
#2
- Biosimilar: UDENYCA (pegfilgrastim-cbqv)
- Applicant: Coherus
- BLA Approval: Nov. 2, 2018; Dec. 26, 2023 (on-body injector)
- US Launch: Jan. 3, 2019
- Related BPCIA Litigation: Amgen v. Coherus
#3
- Biosimilar: ZIEXTENZO (pegfilgrastim-bmez)
- Applicant: Sandoz
- BLA Approval: Nov. 4, 2019
- US Launch: Nov. 15, 2019
- Related BPCIA Litigation: Amgen v. Sandoz
#4
- Biosimilar: NYVEPRIA (pegfilgrastim-apgf)
- Applicant: Pfizer
- BLA Approval: June 10, 2020
- US Launch: Late 2020 or early 2021
- Related BPCIA Litigation: Amgen v. Hospira
#5
- Biosimilar: FYLNETRA (pegfilgrastim-pbbk)
- Applicant: Amneal/Kashiv
- BLA Approval: May 27, 2022
- US Launch: May 16, 2023
- Related BPCIA Litigation: None
#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
- Biosimilar: CIMERLI (ranibizumab-eqrn)
- Applicant: Coherus
- BLA Approval: August 2, 2022
- US Launch: Oct. 3, 2022
- Related BPCIA Litigation: None
Rituximab+
RITUXAN
#1
- Biosimilar: TRUXIMA (rituximab-abbs)
- Applicant: Celltrion
- BLA Approval: Nov. 28, 2018
- US Launch: Nov. 11, 2019
- Related BPCIA Litigation: Genentech v. Celltrion
#2
- Biosimilar: RUXIENCE (rituximab-pvvr)
- Applicant: Pfizer
- BLA Approval: July 23, 2019
- US Launch: Jan. 23, 2020
- Related BPCIA Litigation: None
#3
- Biosimilar: RIABNI (rituximab-arrx)
- Applicant: Amgen
- BLA Approval: Dec. 17, 2020
- US Launch: Jan. 12, 2021
- Related BPCIA Litigation: None
Tocilizumab+
ACTEMRA
#1
- Biosimilar: TOFIDENCE (tocilizumab-bavi)
- Applicant: Biogen
- BLA Approval: Sept. 29, 2023
- US Launch: May 6, 2024
- Related BPCIA Litigation: Genentech v. Biogen
#2
- Biosimilar: TYENNE (tocilizumab-aazg)
- Applicant: Fresenius
- BLA Approval: March 5, 2024
- US Launch: April 15, 2024 (intravenous); July 2, 2024 (subcutaneous)
- Related BPCIA Litigation: None
Trastuzumab+
HERCEPTIN
#1
- Biosimilar: OGIVRI (trastuzumab-dkst)
- Applicant: Mylan
- BLA Approval: Dec. 1, 2017
- US Launch: Dec. 2, 2019
- Related BPCIA Litigation: None
#2
- Biosimilar: HERZUMA (trastuzumab-pkrb)
- Applicant: Celltrion
- BLA Approval: Dec. 14, 2018
- US Launch: Mar. 16, 2020
- Related BPCIA Litigation: Genentech v. Celltrion
#3
- Biosimilar: ONTRUZANT (trastuzumab-dttb)
- Applicant: Samsung Bioepis
- BLA Approval: Jan. 18, 2019
- US Launch: Apr. 15, 2020
- Related BPCIA Litigation: Genentech v. Samsung Bioepis
#4
- Biosimilar: TRAZIMERA (trastuzumab-qyyp)
- Applicant: Pfizer
- BLA Approval: Mar. 11, 2019
- US Launch: Feb. 15, 2020
- Related BPCIA Litigation: Genentech v. Pfizer
#5
- Biosimilar: KANJINTI (trastuzumab-anns)
- Applicant: Amgen
- BLA Approval: June 13, 2019
- US Launch: July 19, 2019
- Related BPCIA Litigation: Genentech v. Amgen
#6
- Biosimilar: HERCESSI (trastuzumab-strf)
- Applicant: Accord BioPharma
- BLA Approval: April 29, 2024 (150 mg); Sept. 6, 2024 (420 mg)
- US Launch: Dec. 2, 2024
- Related BPCIA Litigation: N/A
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
- Biosimilar: SELARSDI (ustekinumab-aekn)
- Applicant: Alvotech
- BLA Approval: April 16, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose vial); Oct. 18, 2024 (130 mg/26 mL single-dose vial)
- US Launch: N/A
- Related BPCIA Litigation: None
#3
- Biosimilar: PYZCHIVA (ustekinumab-ttwe)
- Applicant: Samsung Bioepis
- BLA Approval: July 1, 2024
- US Launch: N/A
- Related BPCIA Litigation: None
#4
- Biosimilar: OTULFI (ustekinumab-aauz)
- Applicant: Fresenius Kabi
- BLA Approval: Sept. 27, 2024
- US Launch: N/A
- Related BPCIA Litigation: None
#5
- Biosimilar: IMULDOSA (ustekinumab-srlf)
- Applicant: Accord Biopharma
- BLA Approval: Oct. 10, 2024
- US Launch: N/A
- Related BPCIA Litigation: None
#6
- Biosimilar: YESINTEK (ustekinumab-kfce)
- Applicant: Biocon Biologics Ltd.
- BLA Approval: Dec. 1, 2024
- US Launch: N/A
- Related BPCIA Litigation: None
Last updated: December 3, 2024