PFIZER

Adalimumab Injection (adalimumab) (Pfizer Canada) (February-2021)Nivestym® (filgrastim) (Pfizer) (April-2020)Ruxience® (rituximab) (Pfizer) (May-2020)Trazimera® (trastuzumab) (Pfizer) (August-2019)Zirabev® (bevacizumab) (Pfizer) (June-2019)

Biosimilars Approved In The E.U.

Amsparity (adalimumab) (Pfizer) (February-2020)Nyvepria® (pegfilgrastim) (Pfizer) (November-2020)Ruxience® (rituximab) (Pfizer) (April-2020)Trazimera® (trastuzumab) (Pfizer) (July-2018)Zirabev® (bevacizumab) (Pfizer) (February-2019)

Biosimilars Approved In Australia

Abrilada (adalimumab) (Pfizer) (February-2021)Nivestim® (filgrastim) (Pfizer) (September-2010)Ruxience® (rituximab) (Pfizer) (March-2021)Trazimera® (trastuzumab) (Pfizer) (August-2019)Zirabev® (bevacizumab) (Pfizer) (November-2019)

Biosimilars Approved In Japan

Infliximab BS 3 (infliximab) (Pfizer) (July-2018)

Inter Partes Review Proceedings

HEMGENIXIPR2020-00388
IPR2021-00925
IPR2021-00926
IPR2021-00928
LANTUS / LANTUS SOLOSTARIPR2019-00977
IPR2019-00978
IPR2019-00979
IPR2019-00980
IPR2019-00981
IPR2019-00982
IPR2019-00987
IPR2019-01022
IPR2019-01023
AVASTIN / ZIRABEVIPR2016-01771
IPR2018-00373
HERCEPTIN / TRAZIMERAIPR2017-00731
IPR2017-00737
IPR2017-00739
IPR2017-00804
IPR2017-00805
IPR2017-01488
IPR2017-01489
IPR2017-01726
IPR2017-01727
IPR2017-02019
IPR2017-02020
IPR2017-02063
IPR2018-00016
IPR2018-00330
IPR2018-00331
NEUPOGEN / NEULASTA / NIVESTYM / NYVEPRIAIPR2021-00528
RITUXAN / RUXIENCEIPR2017-01115
IPR2017-01166
IPR2017-01167
IPR2017-01168
IPR2017-01923
IPR2017-02126
IPR2017-02127
IPR2018-00086
IPR2018-00186
IPR2018-00231
IPR2018-00285

U.S. Patent Litigations

AVASTIN / ZIRABEV1:19-cv-00638 (D. Del.)
AVONEX / BETASERON / EXTAVIA / REBIF2:10-cv-02734 (D.N.J.)
2:10-cv-02760 (D.N.J.)
HERCEPTIN / TRAZIMERA / GENENTECH CABILLY1:17-cv-01672 (D. Del.)
NEULASTA / NYVEPRIA1:20-cv-00201 (D. Del.)
NEUPOGEN / NIVESTYM1:18-cv-01064 (D. Del.)
1:20-cv-00561 (D. Del.)
OPDIVO / BAVENCIO1:17-cv-01029 (D. Del.)

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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