CELLTRION

CELLTRION

approved_indications FDA Approved Biologics and Pending Applications

Herzuma®

trastuzumab-pkrb
aBL 761091

Inflectra®

Infliximab-dyyb
aBL 125544

Remsima® SC

infliximab
Remsima® SC Approval Pending

Truxima®

rituximab-abbs
aBL 761088

Vegzelma®

bevacizumab-adcd
aBL 761268

Yuflyma®

adalimumab-aaty
aBL 761219

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Herzuma® (trastuzumab) (Celltrion / Teva) (September-2019)Remsima (infliximab) (Celltrion) (January-2014) Remsima SC (subcutaneous infliximab) (Celltrion) (February-2021)Remsima SC (subcutaneous infliximab) (Celltrion) (February-2021)Remsima SC (subcutaneous infliximab) (Celltrion) (February-2021)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) Blitzima (rituximab) (Celltrion) (July-2017) Herzuma® (trastuzumab) (Celltrion) (February-2018)Remsima (infliximab) (Celltrion) (September-2013) Remsima SC (subcutaneous infliximab) (Celltrion) (November-2019)Ritemvia (rituximab) (Celltrion (July-2017) Ritemvia (rituximab) (Celltrion (July-2017) Rituzena (rituximab) (Celltrion) (July-2017)Rituzena (rituximab) (Celltrion) (July-2017)Truxima® (rituximab) (Celltrion) (February-2017) Vegzelma® (bevacizumab) (Celltrion) (August-2022, UK: September-2022)Yuflyma (high-concentration adalimumab) (Celltrion) (February-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® (rituximab) (Celltrion) (April-2018)

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

Herzuma® (trastuzumab) (Celltrion) (January-2014)Remsima (infliximab) (Celltrion) (July-2012) Truxima® (CT P10) (rituximab) (Celltrion) (November-2016)Yuflyma (high-concentration adalimumab) (Celltrion) (October-2021)

approved_indications Inter Partes Review Proceedings

ACTEMRAIPR2022-00578
IPR2022-00579
EYLEAIPR2022-00257
IPR2022-00258
IPR2023-00462
IPR2023-00532
IPR2023-00533
IPR2023-00620
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

approved_indications U.S. Patent Litigations

HERCEPTIN / HERZUMA / GENENTECH CABILLY1:18-cv-00095 (D. Del.)
1:18-cv-01025 (D. Del.)
4:18-cv-00274 (N.D. Cal.)
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.)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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