FDA Approvals

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

Adalimumab+

HUMIRA

Biosimilar: AMJEVITA (adalimumab-atto)
Applicant: Amgen
BLA Approval: Sept. 23, 2016
US Launch: Jan, 31, 2023
Related BPCIA Litigation: AbbVie v. Amgen, No. 16-666 (D. Del.)

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); Apr. 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, No. 17-1605 (D. Del.)

Biosimilar: HYRIMOZ (adalimumab-adaz)
Applicant: Sandoz
BLA Approval: Oct. 30, 2018 (50 mg/ml); Mar. 21, 2023 (100 mg/ml)
US Launch: July 1, 2023
Related BPCIA Litigation: AbbVie v. Sandoz, No. 18-12668 (D.N.J.)

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

Biosimilar: ABRILADA (adalimumab-afzb)
Applicant: Pfizer
BLA Approval: Nov. 15, 2019; Oct. 5, 2023 (interchangeable status)
US Launch: Oct. 2023
Related BPCIA Litigation: None

Biosimilar: HULIO (adalimumab-fkjp)
Applicant: Mylan
BLA Approval: July 6, 2020
US Launch: July 3, 2023
Related BPCIA Litigation: None

Biosimilar: YUSIMRY (adalimumab-aqvh)
Applicant: Coherus
BLA Approval: Dec. 20, 2021
US Launch: July 1, 2023
Related BPCIA Litigation: None

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

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: Feb. 23, 2024 (40 mg/0.4 mL, interchangeable).
US Launch: May 20, 2024
Related BPCIA Litigation: AbbVie v. Alvotech, Nos. 21-2258, 21-2899 (N.D. Ill.); No. 2-21-00265 (E.D. Va.)

Aflibercept+

EYLEA

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, No. 1:22-cv-00061 (N.D. W. Va.)

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, Nos. 1:23-cv-00094, 1:23-cv-00106 (N.D. W.Va.)

Biosimilar: FYB203/AHZANTIVE (aflibercept-mrbb)
Applicant: Formycon
BLA Approval: June 28, 2024
US Launch: TBD
Related BPCIA Litigation: Regeneron v. Formycon, No. 1:23-cv-00097 (N.D. W. Va.)

Biosimilar: ENZEEVU (aflibercept-abzv)
Applicant: Sandoz
BLA Approval: Aug. 9, 2024
US Launch: TBD
Related BPCIA Litigation: Regeneron v. Sandoz, No. 1:24-cv-00085 (N.D. W. Va.)

Biosimilar: PAVBLU (aflibercept-ayyh)
Applicant: Amgen
BLA Approval: Aug. 23, 2024
US Launch: Oct. 30, 2024
Related BPCIA Litigation: Regeneron v. Amgen, 1:23-cv-00039 (N.D. W. Va.)

Bevacizumab+

AVASTIN

Biosimilar: MVASI (bevacizumab-awwb)
Applicant: Amgen
BLA Approval: Sept. 14, 2017
US Launch: July 19, 2019
Related BPCIA Litigation: Genentech v. Amgen, Nos. 17-1407, 17-1471, 19-602 (D. Del.)

Biosimilar: ZIRABEV (bevacizumab-bvzr)
Applicant: Pfizer
aBLA Approval: June 28, 2019
US Launch: Dec. 31, 2019
Related BPCIA Litigation: Genentech v. Pfizer, No. 19-638 (D. Del.)

Biosimilar: ALYMSYS (bevacizumab-maly)
Applicant: Amneal/mAbxience
BLA Approval: Apr. 13, 2022
US Launch: Oct. 3, 2022
Related BPCIA Litigation: None

Biosimilar: VEGZELMA (bevacizumab-adcd)
Applicant: Celltrion
BLA Approval: Sept. 27, 2022
US Launch: April 17, 2023
Related BPCIA Litigation: None

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

Biosimilar: JOBEVNE (bevacizumab-nwgd)
Applicant: BioCon Ltd.
BLA Approval: Apr. 10, 2025
US Launch: N/A
Related BPCIA Litigation: None

Denosumab+

PROLIA

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

XGEVA

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

PROLIA

Biosimilar: OSPOMYV (denosumab-dssb)
Applicant: Samsung Bioepis
BLA Approval: Feb. 13, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen v. Samsung Bioepis Co., Ltd., No. 1-24-cv-08417 (D.N.J.)

XGEVA

Biosimilar: XBRYK (denosumab-dssb)
Applicant: Samsung Bioepis
BLA Approval: Feb. 13, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen Inc. v. Samsung Bioepis Co., Ltd., No. 1-24-cv-08417 (D.N.J.)

PROLIA

Biosimilar: STOBOCLO (denosumab-bmwo)
Applicant: Celltrion
BLA Approval: Feb. 28, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen Inc. et al. v. Celltrion, Inc. et al., 1-24-cv-06497 (D.N.J.)

XGEVA

Biosimilar: OSENVELT (denosumab-bmwo)
Applicant: Celltrion
BLA Approval: Feb. 28, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen Inc. et al. v. Celltrion, Inc. et al., 1-24-cv-06497 (D.N.J.)

PROLIA

Biosimilar: CONEXXENCE (denosumab-bnht)
Applicant: Fresenius
BLA Approval: Mar. 25, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al, 1-24-cv-09555 (N.D. Ill.); 1-25-cv-01080 (D.N.J.)

XGEVA

Biosimilar: BOMYNTRA (denosumab-bnht)
Applicant: Fresenius
BLA Approval: Mar. 25, 2025
US Launch: N/A
Related BPCIA Litigation: Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al, 1-24-cv-09555 (N.D. Ill.); 1-25-cv-01080 (D.N.J.)

Eculizumab+

SOLIRIS

Biosimilar: BKEMV (eculizumab-aeeb)
Applicant: Amgen
BLA Approval: May 28, 2024 (interchangeable)
US Launch: Mar. 1, 2025
Related BPCIA Litigation: N/A

Biosimilar: EPYSQLI (eculizumab-aagh)
Applicant: Samsung Bioepis
BLA Approval: July 22, 2024
US Launch: Apr. 7, 2025
Related BPCIA Litigation: Alexion Pharmaceuticals, Inc. et al. v. Samsung Bioepis Co. Ltd., No. 1-24-cv-00005 (D. Del.)

Epoetin Alfa+

EPOGEN/ PROCRIT

Biosimilar: RETACRIT (epoetin alfa-epbx)
Applicant: Hospira
BLA Approval: May 15, 2018
US Launch: Nov. 12, 2018
Related BPCIA Litigation: Amgen v. Hospira, No. 15-839 (D. Del.)

Etanercept+

ENBREL

Biosimilar: ERELZI (etanercept-szzs)
Applicant: Sandoz
BLA Approval: Aug. 30, 2016
US Launch: TBD
Related BPCIA Litigation: Immunex v. Sandoz, No. 16-01118 (D. N.J.)

Biosimilar: ETICOVO (etanercept-ykro)
Applicant: Samsung Bioepis
BLA Approval: Apr. 25, 2019
US Launch: TBD
Related BPCIA Litigation: Immunex v. Samsung Bioepis, No. 19-11755 (D. N.J.)

Filgrastim+

NEUPOGEN

Biosimilar: ZARXIO (filgrastim-sndz)
Applicant: Sandoz
BLA Approval: Mar. 6, 2015
US Launch: Sept. 3, 2015
Related BPCIA Litigation: Amgen v. Sandoz, No. 14-4741 (N.D. Cal.)

Biosimilar: NIVESTYM (filgrastim-aafi)
Applicant: Pfizer
BLA Approval: July 20, 2018
US Launch: Oct. 1, 2018
Related BPCIA Litigation: Amgen v. Hospira, Nos. 18-1064, 20-561 (D. Del.)

Biosimilar: RELEUKO (filgrastim-ayow)
Applicant: Amneal/Kashiv
BLA Approval: Mar. 1, 2022
US Launch: Nov. 22, 2022
Related BPCIA Litigation: None

Biosimilar: NYPOZI (TX-01) (filgrastim-txid)
Applicant: Tanvex BioPharma USA, Inc.
BLA Approval: June 28, 2024
US Launch: N/A
Related BPCIA Litigation: Amgen v. Tanvex, No. 19-1374 (S.D. Cal.)

Infliximab+

REMICADE

Biosimilar: INFLECTRA (infliximab-dyyb)
Applicant: Celltrion
BLA Approval: Apr. 5, 2016
US Launch: Nov. 21, 2016
Related BPCIA Litigation: Janssen v. Celltrion, No. 17-11008 (D. Mass.)

Biosimilar: RENFLEXIS (infliximab-abda)
Applicant: Samsung Bioepis
BLA Approval: Apr. 21, 2017
US Launch: July 24, 2017
Related BPCIA Litigation: Janssen v. Samsung Bioepis, No. 17-3524 (D. N.J.)

Biosimilar: IXIFI (infliximab-qbtx)
Applicant: Pfizer
BLA Approval: Dec. 13, 2017
US Launch: TBD
Related BPCIA Litigation: None

Biosimilar: AVSOLA (infliximab-axxq)
Applicant: Amgen
BLA Approval: Dec. 6, 2019
US Launch: July 2020
Related BPCIA Litigation: None

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

Insulin Aspart+

NOVOLOG

Biosimilar: MERILOG (insulin aspart-szjj)
Applicant: Sanofi-Aventis U.S. LLC.
BLA Approval: Feb. 14, 2025
US Launch: N/A
Related BPCIA Litigation: None

Insulin Glargine+

LANTUS

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

Biosimilar: REZVOGLAR (insulin glargine-aglr)
Applicant: Eli Lilly
BLA Approval: Dec. 20, 2021 (original approval); Nov. 16, 2022 (approved as an interchangeable)
US Launch: Apr. 1, 2023
Related BPCIA Litigation: None

Natalizumab+

TYSABRI

Biosimilar: TYRUKO (natalizumab-sztn)
Applicant: Sandoz
BLA Approval: Aug. 24, 2023
US Launch: N/A
Related BPCIA Litigation: Biogen v. Sandoz, No. 1:22-cv-1190 (D. Del.)

Omalizumab+

XOLAIR

Biosimilar: OMLYCLO (omalizumab-igec)
Applicant: Celltrion
BLA Approval: Mar. 9, 2025
US Launch: N/A
Related BPCIA Litigation: None

Pegfilgrastim+

NEULASTA

Biosimilar: FULPHILA (pegfilgrastim-jmdb)
Applicant: Mylan
BLA Approval: June 4, 2018
US Launch: July 26, 2018
Related BPCIA Litigation: Amgen v. Mylan, No. 17-1235 (W.D. Pa.)

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, No. 17-546 (D. Del.)

Biosimilar: ZIEXTENZO (pegfilgrastim-bmez)
Applicant: Sandoz
BLA Approval: Nov. 4, 2019
US Launch: Nov. 15, 2019
Related BPCIA Litigation: Amgen v. Sandoz, No. 16-2581 (N.D. Cal.)

Biosimilar: NYVEPRIA (pegfilgrastim-apgf)
Applicant: Pfizer
BLA Approval: June 10, 2020
US Launch: Late 2020 or early 2021
Related BPCIA Litigation: Amgen v. Hospira, No. 20-201 (D. Del.)

Biosimilar: FYLNETRA (pegfilgrastim-pbbk)
Applicant: Amneal/Kashiv
BLA Approval: May 27, 2022
US Launch: May 16, 2023
Related BPCIA Litigation: None

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

Ranibizumab+

LUCENTIS

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

Biosimilar: CIMERLI (ranibizumab-eqrn)
Applicant: Coherus
BLA Approval: Aug. 2, 2022
US Launch: Oct. 3, 2022
Related BPCIA Litigation: None

Rituximab+

RITUXAN

Biosimilar: TRUXIMA (rituximab-abbs)
Applicant: Celltrion
BLA Approval: Nov. 28, 2018
US Launch: Nov. 11, 2019
Related BPCIA Litigation: Genentech v. Celltrion, Nos. 1-18-cv-00574, 18-cv-11553 (D.N.J.)

Biosimilar: RUXIENCE (rituximab-pvvr)
Applicant: Pfizer
BLA Approval: July 23, 2019
US Launch: Jan. 23, 2020
Related BPCIA Litigation: None

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

Tocilizumab+

ACTEMRA

Biosimilar: TOFIDENCE (tocilizumab-bavi)
Applicant: Biogen
BLA Approval: Sept. 29, 2023
US Launch: May 6, 2024
Related BPCIA Litigation: Genentech v. Biogen, No. 1:23-cv-11573 (D. Mass.)

Biosimilar: TYENNE (tocilizumab-aazg)
Applicant: Fresenius
BLA Approval: Mar. 5, 2024
US Launch: Apr. 15, 2024 (intravenous); July 2, 2024 (subcutaneous)
Related BPCIA Litigation: None

Biosimilar: AVTOZMA (tocilizumab-anoh)
Applicant: Celltrion
BLA Approval: Jan. 31, 2025
US Launch: N/A
Related BPCIA Litigation: None

Trastuzumab+

HERCEPTIN

Biosimilar: OGIVRI (trastuzumab-dkst)
Applicant: Mylan
BLA Approval: Dec. 1, 2017
US Launch: Dec. 2, 2019
Related BPCIA Litigation: None

Biosimilar: HERZUMA (trastuzumab-pkrb)
Applicant: Celltrion
BLA Approval: Dec. 14, 2018
US Launch: Mar. 16, 2020
Related BPCIA Litigation: Genentech v. Celltrion, Nos. 1-18-cv-00095, 1:18-cv-01025 (D. Del.)

Biosimilar: ONTRUZANT (trastuzumab-dttb)
Applicant: Samsung Bioepis
BLA Approval: Jan. 18, 2019
US Launch: Apr. 15, 2020
Related BPCIA Litigation: Genentech v. Samsung Bioepis, No. 1:18-cv-1363 (D. Del.)

Biosimilar: TRAZIMERA (trastuzumab-qyyp)
Applicant: Pfizer
BLA Approval: Mar. 11, 2019
US Launch: Feb. 15, 2020
Related BPCIA Litigation: Genentech v. Pfizer, No. 17-1672 (D. Del.)

Biosimilar: KANJINTI (trastuzumab-anns)
Applicant: Amgen
BLA Approval: June 13, 2019
US Launch: July 19, 2019
Related BPCIA Litigation: Genentech v. Amgen, No. 18-924 (D. Del.)

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

Biosimilar: WEZLANA (ustekinumab-auub)
Applicant: Amgen
BLA Approval: Oct. 31, 2023 (45 mg/0.5 mL and 90 mg/1 mL single-dose vial or syringe, interchangeable); Oct. 18, 2024 (130 mg/26 mL single-dose vial)
US Launch: Jan. 1, 2025
Related BPCIA Litigation: Janssen Biotech v. Amgen, 1:22-CV-1549 (D. Del.)

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); Apr. 30, 2025 (interchangeable)
US Launch: Feb. 21, 2025
Related BPCIA Litigation: None

Biosimilar: PYZCHIVA (ustekinumab-ttwe)
Applicant: Samsung Bioepis
BLA Approval: July 1, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose syringe; 130 mg/26 mL single-dose vial); Apr. 30, 2025 (interchangeable)
US Launch: Feb. 24, 2025
Related BPCIA Litigation: None

Biosimilar: OTULFI (ustekinumab-aauz)
Applicant: Fresenius Kabi
BLA Approval: Sept. 27, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose syringe; 130 mg/26 mL single-dose vial); Apr. 30, 2025 (interchangeable)
US Launch: Mar. 3, 2025
Related BPCIA Litigation: None

Biosimilar: IMULDOSA (ustekinumab-srlf)
Applicant: Accord Biopharma
BLA Approval: Oct. 10, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose syringe; 130 mg/26 mL single-dose vial)
US Launch: N/A
Related BPCIA Litigation: None

Biosimilar: YESINTEK (ustekinumab-kfce)
Applicant: Biocon Biologics Ltd.
BLA Approval: Dec. 1, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose vial and syringe; 130 mg/26 mL single-dose vial); Apr. 30, 2025 (interchangeable)
US Launch: Feb. 24, 2025
Related BPCIA Litigation: None

Biosimilar: STEQEYMA (ustekinumab-stba)
Applicant: Celltrion
BLA Approval: Dec. 17, 2024 (45 mg/0.5 mL and 90 mg/1 mL single-dose syringe; 130 mg/26 mL single-dose vial); Apr. 30, 2025 (interchangeable)
US Launch: Mar. 12, 2025
Related BPCIA Litigation: None

Last updated: May 13, 2025