HOSPIRA

FDA Approved Biologics and Pending Applications

Inflectra®

Infliximab-dyyb
aBL 125544

Nyvepria®

pegfilgrastim-apgf
aBL 761111

Retacrit®

epoetin alfa-epbx
aBL 125545

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Inflectra (infliximab) (Hospira) (January-2014)

Biosimilars Approved In The E.U.

Inflectra (infliximab) (Hospira) (September-2013)Nivestim® (filgrastim) (Hospira) (June-2010)Retacrit (epoetin zeta) (Hospira) (December-2007)

Biosimilars Approved In Australia

Inflectra / Remsima / Emisima / Flixceli (infliximab) (Hospira / Pharmbio) (August-2015)

Inter Partes Review Proceedings

LANTUS / LANTUS SOLOSTARIPR2019-00977
IPR2019-00978
IPR2019-00979
IPR2019-00980
IPR2019-00981
IPR2019-00982
IPR2019-00987
IPR2019-01022
IPR2019-01023
AVASTIN / ZIRABEVIPR2016-01771
EPOGEN / PROCRIT / RETACRITIPR2013-00365
HERCEPTIN / TRAZIMERAIPR2016-01837
IPR2017-00731
IPR2017-00737
IPR2017-00739
IPR2017-00804
IPR2017-00805

U.S. Patent Litigations

EPOGEN / PROCRIT / RETACRIT1:15-cv-00839 (D. Del.)
NEULASTA / NYVEPRIA1:20-cv-00201 (D. Del.)
NEUPOGEN / NIVESTYM1:18-cv-01064 (D. Del.)
1:20-cv-00561 (D. Del.)
REMICADE / INFLECTRA1:14-cv-07049 (S.D.N.Y.)
1:15-cv-10698 (D. Mass.)
1:16-cv-11117 (D. Mass.)
1:17-cv-11008 (D. Mass.)

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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