FDA Approved Biologics and Pending Applications
trastuzumab-pkrb
aBL 761091
Infliximab-dyyb
aBL 125544
infliximab
Remsima® SC Approval Pending
rituximab-abbs
aBL 761088
bevacizumab-adcd
aBL 761268
adalimumab-aaty
aBL 761219
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)
Inter Partes Review Proceedings
ACTEMRAIPR2022-00578IPR2022-00579EYLEAIPR2022-00257IPR2022-00258IPR2023-00462IPR2023-00532IPR2023-00533IPR2023-00620PGR2021-00117HERCEPTIN / HERZUMAIPR2017-00959IPR2017-01121IPR2017-01122IPR2017-01139IPR2017-01140IPR2017-01373IPR2017-01374RITUXAN / TRUXIMAIPR2015-01733IPR2015-01744IPR2016-01614IPR2016-01667IPR2017-01093IPR2017-01094IPR2017-01095IPR2017-01227IPR2017-01229IPR2017-01230IPR2018-01019
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.)