To view our full FDA Approvals tracking table, click here.
Adalimumab+
HUMIRA
#1
- 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.)
#2
- Biosimilar: CYLTEZO (adalimumab-adbm)
- Applicant: Boehringer Ingelheim
- BLA Approval: Aug. 25, 2017
- US Launch: July 1, 2023
- Related BPCIA Litigation: AbbVie v. BI, No. 17-1065 (D. Del.)
#3
- Biosimilar: HYRIMOZ (adalimumab-adaz)
- Applicant: Sandoz
- BLA Approval: Oct. 30, 2018
- US Launch: July 1, 2023
- Related BPCIA Litigation: AbbVie v. Sandoz, No. 18-12668 (D.N.J.)
#4
- Biosimilar: HADLIMA (adalimumab-bwwd)
- Applicant: Samsung Bioepis
- BLA Approval: July 23, 2019
- US Launch: July 1, 2023
- Related BPCIA Litigation: None
#5
- Biosimilar: ABRILADA (adalimumab-afzb)
- Applicant: Pfizer
- BLA Approval: Nov. 15, 2019
- US Launch: Oct. 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 3, 2023
- Related BPCIA Litigation: None
#8
- Biosimilar: IDACIO (adalimumab-aacf)
- Applicant: Fresenius Kabi
- BLA Approval: Dec. 14, 2022
- US Launch: July 3, 2023
- Related BPCIA Litigation: None
#9
- Biosimilar: YUFLYMA (adalimumab-aaty)
- Applicant: Celltrion
- BLA Approval: May 23, 2023
- US Launch: July 2, 2023
- Related BPCIA Litigation: None
#10
- Biosimilar: SIMLANDI (adalimumab-ryvk)
- Applicant: Alvotech
- BLA Approval: Feb. 23, 2024
- 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
#1
- Biosimilar: YESAFILI (aflibercept-jbvf)
- Applicant: Biocon Biologics
- BLA Approval: May 20, 2024
- US Launch: TBD
- Related BPCIA Litigation: Regeneron v. Mylan, No. 1:22-cv-00061 (N.D. W. Va.)
#2
- Biosimilar: OPUVIZ (aflibercept-yszy)
- Applicant: Samsung Bioepis Co. Ltd.
- BLA Approval: May 20, 2024
- US Launch: TBD
- Related BPCIA Litigation: Regeneron v. Samsung Bioepis, Nos. 1:23-cv-00094, 1:23-cv-00106 (N.D. W.Va.)
#3
- Biosimilar: 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.)
#4
- 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.)
#5
- Biosimilar: PAVBLU (aflibercept-ayyh)
- Applicant: Amgen
- BLA Approval: Aug. 23, 2024
- US Launch: Oct. 30, 2024
- Related BPCIA Litigation: Regeneron v. Amgen, Nos. 1:24-cv-00039, 1:25-cv-00074 (N.D. W. Va.)
#6
- Biosimilar: EYDENZELT (aflibercept-boav)
- Applicant: Celltrion
- BLA Approval: Oct. 2, 2025
- US Launch: N/A
- Related BPCIA Litigation: Regeneron v. Celltrion, Nos. 1:23-CV-00089, 1:24-cv-00053 (N.D. W. Va.)
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, Nos. 17-1407, 17-1471, 19-602 (D. Del.)
#2
- 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.)
#3
- Biosimilar: ALYMSYS (bevacizumab-maly)
- Applicant: Amneal/mAbxience
- BLA Approval: Apr. 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. 6, 2023
- US Launch: N/A
- Related BPCIA Litigation: None
#6
- Biosimilar: JOBEVNE (bevacizumab-nwgd)
- Applicant: BioCon Ltd.
- BLA Approval: Apr. 9, 2025
- US Launch: N/A
- Related BPCIA Litigation: None
Denosumab+
PROLIA
#1
- Biosimilar: JUBBONTI (denosumab-bddz)
- Applicant: Sandoz
- BLA Approval: Mar. 5, 2024
- US Launch: June 2, 2025
- Related BPCIA Litigation: Amgen v. Sandoz, 1:23-CV-02406 (D. N.J.)
XGEVA
#1
- Biosimilar: WYOST (denosumab-bddz)
- Applicant: Sandoz
- BLA Approval: Mar. 5, 2024
- US Launch: June 2, 2025
- Related BPCIA Litigation: Amgen v. Sandoz, 1:23-CV-02406 (D. N.J.)
PROLIA
#2
- 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
#2
- 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
#3
- Biosimilar: STOBOCLO (denosumab-bmwo)
- Applicant: Celltrion
- BLA Approval: Feb. 28, 2025
- US Launch: July 7, 2025
- Related BPCIA Litigation: Amgen Inc. et al. v. Celltrion, Inc. et al., 1-24-cv-06497 (D.N.J.)
XGEVA
#3
- Biosimilar: OSENVELT (denosumab-bmwo)
- Applicant: Celltrion
- BLA Approval: Feb. 28, 2025
- US Launch: July 7, 2025
- Related BPCIA Litigation: Amgen Inc. et al. v. Celltrion, Inc. et al., 1-24-cv-06497 (D.N.J.)
PROLIA
#4
- Biosimilar: CONEXXENCE (denosumab-bnht)
- Applicant: Fresenius
- BLA Approval: Mar. 25, 2025
- US Launch: July 1, 2025
- Related BPCIA Litigation: Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al, 1-24-cv-09555 (N.D. Ill.), transferred to 1-25-cv-01080 (D.N.J.)
XGEVA
#4
- Biosimilar: BOMYNTRA (denosumab-bnht)
- Applicant: Fresenius
- BLA Approval: Mar. 25, 2025
- US Launch: July 1, 2025
- Related BPCIA Litigation: Amgen Inc. et al. v. Fresenius Kabi USA, LLC et al, 1-24-cv-09555 (N.D. Ill.), transferred to 1-25-cv-01080 (D.N.J.)
PROLIA
#5
- Biosimilar: BILDYOS (denosumab-nxxp)
- Applicant: Shanghai Henlius Biotech
- BLA Approval: Aug. 29, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Shanghai Henlius Biotech, Inc., 1-25-cv-12160 (D.N.J.)
XGEVA
#5
- Biosimilar: BILPREVDA (denosumab-nxxp)
- Applicant: Shanghai Henlius Biotech
- BLA Approval: Aug. 29, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Shanghai Henlius Biotech, Inc., 1-25-cv-12160 (D.N.J.)
PROLIA
#6
- Biosimilar: BOSAYA (denosumab-kyqq)
- Applicant: Biocon Biologics Inc.
- BLA Approval: Sept. 16, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Biocon Biologics, Inc. et al., 1-25-cv-13358 (D. Ma.), transferred to 1-25-cv-13358 (D. N.J.)
XGEVA
#6
- Biosimilar: AUKELSO (denosumab-kyqq)
- Applicant: Biocon Biologics Inc.
- BLA Approval: Sept. 16, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Biocon Biologics, Inc. et al., 1-25-cv-13358 (D. Ma.), transferred to 1-25-cv-13358 (D. N.J.)
PROLIA
#7
- Biosimilar: ENOBY (denosumab-qbde)
- Applicant: Hikma Pharmaceuticals
- BLA Approval: Sept. 26, 2025
- US Launch: Jan. 19, 2026
- Related BPCIA Litigation: Amgen Inc. et al. v. Hikma Pharms. USA Inc. et al., 1-25-12152 (D. N.J.)
XGEVA
#7
- Biosimilar: XTRENBO (denosumab-qbde)
- Applicant: Hikma Pharmaceuticals
- BLA Approval: Sept. 26, 2025
- US Launch: Jan. 19, 2026
- Related BPCIA Litigation: Amgen Inc. et al. v. Hikma Pharms. USA Inc. et al., 1-25-12152 (D. N.J.)
PROLIA
#8
- Biosimilar: OSVYRTI (denosumab-desu)
- Applicant: Accord BioPharma Inc.
- BLA Approval: Nov. 20, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Accord Biopharma, Inc. et al, 5-24-cv-00642 (E.D. N.C.), transferred to 1-25-cv-01305 (D.N.J.)
XGEVA
#8
- Biosimilar: JUBEREQ (denosumab-desu)
- Applicant: Accord BioPharma Inc.
- BLA Approval: Nov. 20, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Accord Biopharma, Inc. et al, 5-24-cv-00642 (E.D. N.C.), transferred to 1-25-cv-01305 (D.N.J.)
PROLIA
#9
- Biosimilar: BONCRESA (denosumab-mobz)
- Applicant: Amneal
- BLA Approval: Dec. 22, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Amneal Pharms LLC et al., 1-25-17278 (D. N.J.)
XGEVA
#9
- Biosimilar: OZILTUS (denosumab-mobz)
- Applicant: Amneal
- BLA Approval: Dec. 22, 2025
- US Launch: N/A
- Related BPCIA Litigation: Amgen Inc. et al. v. Amneal Pharms LLC et al., 1-25-17278 (D. N.J.)
Eculizumab+
SOLIRIS
#1
- Biosimilar: BKEMV (eculizumab-aeeb)
- Applicant: Amgen
- BLA Approval: May 28, 2024
- US Launch: Mar. 5, 2025
- Related BPCIA Litigation: N/A
#2
- Biosimilar: EPYSQLI (eculizumab-aagh)
- Applicant: Samsung Bioepis
- BLA Approval: July 19, 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
#1
- 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
#1
- 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.)
#2
- 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
#1
- 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.)
#2
- 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.)
#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 (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
#1
- Biosimilar: INFLECTRA (infliximab-dyyb)
- Applicant: Celltrion
- BLA Approval: Apr. 5, 2016
- US Launch: Nov. 28, 2016
- Related BPCIA Litigation: Janssen v. Celltrion, No. 17-11008 (D. Mass.)
#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, No. 17-3524 (D. N.J.)
#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 Aspart+
NOVOLOG
#1
- Biosimilar: MERILOG (insulin aspart-szjj)
- Applicant: Sanofi-Aventis U.S. LLC.
- BLA Approval: Feb. 14, 2025
- US Launch: N/A
- Related BPCIA Litigation: None
#2
- Biosimilar: KIRSTY (insulin aspart-xjhz)
- Applicant: Biocon Biologics Ltd.
- BLA Approval: July 15, 2025
- US Launch: N/A
- Related BPCIA Litigation: None
Insulin Glargine+
LANTUS
#1
- Biosimilar: SEMGLEE (insulin glargine-yfgn)
- Applicant: Viatris
- BLA Approval: July 28, 2021
- US Launch: Nov. 16, 2021
- Related BPCIA Litigation: None
#2
- Biosimilar: REZVOGLAR (insulin glargine-aglr)
- Applicant: Eli Lilly
- BLA Approval: Dec. 20, 2021
- US Launch: Apr. 1, 2023
- Related BPCIA Litigation: None
Natalizumab+
TYSABRI
#1
- Biosimilar: TYRUKO (natalizumab-sztn)
- Applicant: Sandoz
- BLA Approval: Aug. 24, 2023
- US Launch: Nov. 17, 2025
- Related BPCIA Litigation: Biogen v. Sandoz, No. 1:22-cv-1190 (D. Del.)
Omalizumab+
XOLAIR
#1
- Biosimilar: OMLYCLO (omalizumab-igec)
- Applicant: Celltrion
- BLA Approval: Mar. 7, 2025
- US Launch: N/A
- Related BPCIA Litigation: None
Pegfilgrastim+
NEULASTA
#1
- Biosimilar: FULPHILA (pegfilgrastim-jmdb)
- Applicant: Mylan
- BLA Approval: June 4, 2018
- US Launch: July 2018
- Related BPCIA Litigation: Amgen v. Mylan, No. 17-1235 (W.D. Pa.)
#2
- Biosimilar: UDENYCA (pegfilgrastim-cbqv)
- Applicant: Coherus
- BLA Approval: Nov. 2, 2018
- US Launch: Jan. 3, 2019
- Related BPCIA Litigation: Amgen v. Coherus, No. 17-546 (D. Del.)
#3
- 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.)
#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, No. 20-201 (D. Del.)
#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: Feb. 16, 2023
- Related BPCIA Litigation: None
#7
- Biosimilar: ARMLUPEG (pegfilgrastim-unne)
- Applicant: Lupin
- BLA Approval: Dec. 1, 2025
- US Launch: N/A
- Related BPCIA Litigation: None
Pertuzumab+
PERJETA
#1
- Biosimilar: POHERDY (pertuzumab-dpzb)
- Applicant: Shanghai Henlius Biotech
- BLA Approval: Nov. 13, 2025
- US Launch: TBD
- Related BPCIA Litigation: Genentech v. Shanghai Henlius Biotech, No. 2:25-cv-14648 (D. N.J.)
Ranibizumab+
LUCENTIS
#1
- Biosimilar: BYOOVIZ (ranibizumab-nuna)
- Applicant: Biogen/Samsung Bioepis
- BLA Approval: Sep. 20, 2021
- US Launch: June 2, 2022
- Related BPCIA Litigation: None
#2
- Biosimilar: CIMERLI (ranibizumab-eqrn)
- Applicant: Coherus
- BLA Approval: Aug. 2, 2022
- US Launch: Oct. 3, 2022
- Related BPCIA Litigation: None
#3
- Biosimilar: NUFYMCO (ranibizumab-leyk)
- Applicant: Formycon AG
- BLA Approval: Dec. 18, 2025
- US Launch: N/A
- 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, Nos. 1-18-cv-00574, 18-cv-11553 (D.N.J.)
#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, No. 1:23-cv-11573 (D. Mass.)
#2
- Biosimilar: TYENNE (tocilizumab-aazg)
- Applicant: Fresenius
- BLA Approval: Mar. 5, 2024
- US Launch: Apr. 15, 2024
- Related BPCIA Litigation: None
#3
- Biosimilar: AVTOZMA (tocilizumab-anoh)
- Applicant: Celltrion
- BLA Approval: Jan. 24, 2025
- US Launch: Oct. 2, 2025
- 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, Nos. 1-18-cv-00095, 1:18-cv-01025 (D. Del.)
#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, No. 1:18-cv-1363 (D. Del.)
#4
- 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.)
#5
- 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.)
#6
- Biosimilar: HERCESSI (trastuzumab-strf)
- Applicant: Accord BioPharma
- BLA Approval: April 29, 2024
- US Launch: Dec. 2, 2024
- Related BPCIA Litigation: N/A
Ustekinumab+
STELARA
#1
- Biosimilar: WEZLANA (ustekinumab-auub)
- Applicant: Amgen
- BLA Approval: Oct. 31, 2023
- U.S. Launch: Jan. 1, 2025
- 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
- US Launch: Feb. 21, 2025
- Related BPCIA Litigation: None
#3
- Biosimilar: PYZCHIVA (ustekinumab-ttwe)
- Applicant: Samsung Bioepis
- BLA Approval: June 28, 2024
- US Launch: Feb. 24, 2025
- Related BPCIA Litigation: None
#4
- Biosimilar: OTULFI (ustekinumab-aauz)
- Applicant: Fresenius Kabi
- BLA Approval: Sept. 27, 2024
- US Launch: Mar. 3, 2025
- Related BPCIA Litigation: None
#5
- Biosimilar: IMULDOSA (ustekinumab-srlf)
- Applicant: Accord Biopharma
- BLA Approval: Oct. 10, 2024
- US Launch: Aug. 18, 2025
- Related BPCIA Litigation: None
#6
- Biosimilar: YESINTEK (ustekinumab-kfce)
- Applicant: Biocon Biologics Ltd.
- BLA Approval: Nov. 29, 2024
- US Launch: Feb. 24, 2025
- Related BPCIA Litigation: None
#7
- Biosimilar: STEQEYMA (ustekinumab-stba)
- Applicant: Celltrion
- BLA Approval: Dec. 17, 2024
- US Launch: Mar. 12, 2025
- Related BPCIA Litigation: None
#8
- Biosimilar: STARJEMZA (ustekinumab-hmny)
- Applicant: Bio-Thera
- BLA Approval: May 22, 2025
- US Launch: Nov. 6, 2025
- Related BPCIA Litigation: None
Last updated: Feb. 10, 2026