FRESENIUS KABI

FRESENIUS KABI

approved_indications FDA Approved Biologics and Pending Applications

Chorionic Gonadotropin

chorionic gonadotropin
BL 017067

DRL_RI

rituximab
DRL_RI Approval Pending

FKS518

denosumab
FKS518 Approval Pending

Idacio®

adalimumab-aacf
aBL 761255

Otulfi

ustekinumab-aauz
aBL 761379

Stimufend®

pegfilgrastim-fpgk
aBL 761173

Tyenne®

tocilizumab-aazg
aBL 761275

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Idacio® (adalimumab) (Fresenius Kabi) (October-2020)

Biosimilars Approved In The E.U.

Idacio® (adalimumab) (Fresenius Kabi) (April-2019) Kromeya (adalimumab) (Fresenius Kabi) (April-2019) Otulfi (Fresenius Kabi) (ustekinumab) (September-2024)Stimufend® (pegfilgrastim) (Fresenius Kabi) (March-2022)Tyenne® (tocilizumab) (Fresenius Kabi) (September-2023)

Biosimilars Approved In Australia

Idacio® (adalimumab) (Fresenius Kabi) (June-2020)

approved_indications Inter Partes Review Proceedings

ACTEMRA / TYENNEIPR2021-01024
IPR2021-01025
IPR2021-01288
IPR2021-01336
IPR2021-01542
IPR2022-00201
IPR2022-01065
NEULASTA / STIMUFENDIPR2019-00971
IPR2019-01183
IPR2020-00314
NEUPOGEN / NEULASTA / STIMUFENDIPR2019-01183
YUSIMRY / IDACIOPGR2019-00064

approved_indications U.S. Patent Litigations

PROLIA / XGEVA / FKS5181:24-cv-09555 (N.D. Ill.)
RITUXAN / DRL_RI1:23-cv-22485 (D.N.J.)

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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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