PFIZER

PFIZER

approved_indications FDA Approved Biologics and Pending Applications

Abrilada

adalimumab-afzb
aBL 761118

Elelyso®

taliglucerase alfa
BL 022458

Genotropin®

somatropin
BL 020280

Inflectra®

Infliximab-dyyb
aBL 125544

Ixifi

infliximab-qbtx
aBL 761072

Nivestym

filgrastim-aafi
aBL 761080

Nyvepria

pegfilgrastim-apgf
aBL 761111

Retacrit®

epoetin alfa-epbx
aBL 125545

Ruxience®

rituximab-pvvr
aBL 761103

Somavert®

pegvisomant
BL 021106

Trazimera

trastuzumab-qyyp
aBL 761081

Zirabev

bevacizumab-bvzr
aBL 761099

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

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)Yuflyma (high-concentration adalimumab) (Celltrion) (February-2021)Zirabev (bevacizumab) (Pfizer) (February-2019)

Biosimilars Approved In Australia

Nivestim (filgrastim) (Pfizer) (September-2010)

Biosimilars Approved In Japan

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

approved_indications 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
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

approved_indications 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.)

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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