CELLTRION

FDA Approved Biologics and Pending Applications

CT-P39

omalizumab
CT-P39 Approval Pending

CT-P41

denosumab
CT-P41 Approval Pending

CT-P42

aflibercept
CT-P42 Approval Pending

CT-P43

ustekinumab
CT-P43 Approval Pending

CT-P47

tocilizumab
CT-P47 Approval Pending

Herzuma®

trastuzumab-pkrb
aBL 761091

Inflectra®

Infliximab-dyyb
aBL 125544

Truxima®

rituximab-abbs
aBL 761088

Vegzelma®

bevacizumab-adcd
aBL 761268

Yuflyma®

adalimumab-aaty
aBL 761219

Zymfentra

Infliximab-dyyb (for subcutanous use)
BL 761358

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Herzuma® (trastuzumab) (Celltrion / Teva) (September-2019)Omlyclo® (omalizumab) (Celltrion) (December-2024)Remsima (infliximab) (Celltrion) (January-2014) Remsima SC (subcutaneous infliximab) (Celltrion) (February-2021)SteQeyma® (ustekinumab) (Celltrion) (July-2024)Truxima® (rituximab) (Teva) (April-2019)Vegzelma® (bevacizumab) (Celltrion) (January-2023)Yuflyma® (high-concentration adalimumab) (Celltrion) (December-2021)

Biosimilars Approved In The E.U.

Blitzima (rituximab) (Celltrion) (July-2017) Herzuma® (trastuzumab) (Celltrion) (February-2018)Omlyclo® (omalizumab) (Celltrion) (May-2024 E.U.; July-2024 U.K.)Remsima (infliximab) (Celltrion) (September-2013) Remsima SC (subcutaneous infliximab) (Celltrion) (November-2019)Ritemvia (rituximab) (Celltrion (July-2017) Rituzena (rituximab) (Celltrion) (July-2017)SteQeyma® (ustekinumab) (Celltrion) (August-2024)Truxima® (rituximab) (Celltrion) (February-2017) Vegzelma® (bevacizumab) (Celltrion) (August-2022, UK: September-2022)Yuflyma® (high-concentration adalimumab) (Celltrion) (February-2022)Yuflyma® (low-concentration adalimumab) (Celltrion) (February-2021)

Biosimilars Approved In Australia

Herzuma® (trastuzumab) (Celltrion) (August-2018)Truxima® / Ritemvia® / Rituzena® / Tuxella® (rituximab) (Celltrion) (April-2018)Vegzelma® (bevacizumab) (Celltrion) (September-2023)Yuflyma® (adalimumab) (Celltrion) (February-2022)

Biosimilars Approved In Japan

CT-P6 (trastuzumab) (Celltrion / Nippon Kayaku) (August-2018)Infliximab BS (infliximab) (Remsima) (Celltrion / Nippon Kayaku) (July-2014)Vegzelma® (bevacizumab) (Celltrion) (September-2022)

Biosimilars Approved In South Korea

Eydenzelt (aflibercept) (Celltrion) (May-2024)Herzuma® (trastuzumab) (Celltrion) (January-2014)Omlyclo® (omalizumab) (Celltrion) (June-2024)Remsima (infliximab) (Celltrion) (July-2012) SteQeyma® (ustekinumab) (Celltrion) (June-2024)Stoboclo® / Osenvelt® (denosumab) (Celltrion) (November-2024)Truxima® (CT P10) (rituximab) (Celltrion) (November-2016)Vegzelma® (bevacizumab) (Celltrion) (September-2022)Yuflyma® (high-concentration adalimumab) (Celltrion) (October-2021)

Inter Partes Review Proceedings

ACTEMRA / CT-P47IPR2022-00578
IPR2022-00579
EYLEA / CT-P42IPR2022-00257
IPR2022-00258
IPR2023-00462
IPR2023-00532
IPR2023-00533
IPR2023-00620
IPR2024-00260
PGR2021-00117
HERCEPTIN / HERZUMAIPR2017-00959
IPR2017-01121
IPR2017-01122
IPR2017-01139
IPR2017-01140
IPR2017-01373
IPR2017-01374
RITUXAN / TRUXIMAIPR2015-01733
IPR2015-01744
IPR2016-01614
IPR2016-01667
IPR2017-01093
IPR2017-01094
IPR2017-01095
IPR2017-01227
IPR2017-01229
IPR2017-01230
IPR2018-01019

U.S. Patent Litigations

EYLEA / CT-P421:23-cv-00089 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
HERCEPTIN / HERZUMA / GENENTECH CABILLY1:18-cv-00095 (D. Del.)
1:18-cv-01025 (D. Del.)
4:18-cv-00274 (N.D. Cal.)
PROLIA / XGEVA / CT-P411:24-cv-06497 (D.N.J.)
REMICADE / INFLECTRA1:14-cv-02256 (S.D.N.Y.)
1:14-cv-11613 (D. Mass.)
1:15-cv-10698 (D. Mass.)
1:16-cv-11117 (D. Mass.)
1:17-cv-11008 (D. Mass.)
RITUXAN / TRUXIMA / GENENTECH CABILLY1:18-cv-00574 (D.N.J.)
1:18-cv-11553 (D.N.J.)
4:18-cv-00276 (N.D. Cal.)