AMGEN

AMGEN

approved_indications FDA Approved Biologics and Pending Applications


ABP 980

trastuzumab
ABP 980 Approval Pending

Aimovig

erenumab-aooe
BL 761077

Amjevita

adalimumab-atto
aBL 761024

Aranesp®

darbepoetin alfa
BL 103951

Blincyto®

blinatumomab
BL 125557

Epogen® / Procrit®

epoetin alfa
BL 103234

Mvasi

bevacizumab-awwb
aBL 761028

Neulasta®

pegfilgrastim
BL 125031

Neupogen®

filgrastim
BL 103353

Nplate®

romiplostim
BL 125268

Prolia® / Xgeva®

denosumab
BL 125320

Repatha®

evolocumab
BL 125522

Vectibix®

panitumumab
BL 125147

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Amgevita / Solymbic (adalimumab) (Amgen) (March-2017)Kanjinti (trastuzumab) (Amgen) (May-2018)Mvasi (bevacizumab) (Amgen/Allergan) (January-2018)

Biosimilars Approved In Australia

Amgevita (adalimumab) (Amgen) (November-2017)

approved_indications Inter Partes Review Proceedings


ENBRELIPR2015-01792
HUMIRA / AMJEVITAIPR2015-01514
IPR2015-01517
NEUPOGEN / NEULASTA / GRASTOFILIPR2016-01542
NEUPOGEN / NEULASTA / TPI G-CSF / GRASTOFILPGR2019-00001

approved_indications U.S. Patent Litigations


DUPIXENT1:17-cv-10465 (D. Mass.)
2:17-cv-02613 (C.D. Cal.)
ENBREL1:09-cv-00805 (D. Del.)
2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
NEUPOGEN0:15-cv-62081 (S.D. Fla.)
0:18-cv-61828 (S.D. Fla.)
1:10-cv-01540 (E.D. Ill.)
1:18-cv-01064 (D. Del.)
2:13-cv-04911 (D.N.J.)
2:18-cv-03347 (D.N.J.)
3:14-cv-04741 (N.D. Cal.)
AVASTIN / MVASI1:17-cv-00165 (D. Del.)
1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
AVASTIN / MVASI / GENENTECH CABILLY1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
ENBREL / ERELZI2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
EPOGEN / PROCRIT / RETACRIT1:15-cv-00839 (D. Del.)
GRANIX / NEUPOGEN / NEULASTA2:13-cv-04911 (D.N.J.)
HERCEPTIN / ABP 980 / GENENTECH CABILLY1:18-cv-00924 (D. Del.)
HUMIRA / AMJEVITA1:16-cv-00666 (D. Del.)
NEULASTA / FULPHILA2:17-cv-01235 (W.D. Pa.)
NEULASTA / LA-EP20062:16-cv-01276 (D.N.J.)
3:16-cv-02581 (N.D. Cal.)
NEULASTA / LAPELGA0:15-cv-61631 (S.D. Fla.)
NEULASTA / UDENYCA1:17-cv-00546 (D. Del.)
56-2017-00493553-CU-BT-VTA (CA Sup. Ct.)
NEUPOGEN / GRASTOFIL0:15-cv-62081 (S.D. Fla.)
NEUPOGEN / NEULASTA / GRASTOFIL / LAPELGA0:18-cv-61828 (S.D. Fla.)
NEUPOGEN / NIVESTYM1:18-cv-01064 (D. Del.)
NEUPOGEN / TPI G-CSF2:18-cv-03347 (D.N.J.)
NEUPOGEN / ZARXIO3:14-cv-04741 (N.D. Cal.)
PRALUENT / REPATHA1:14-cv-01317 (D. Del.)
1:14-cv-01349 (D. Del.)
1:14-cv-01393 (D. Del.)
1:14-cv-01414 (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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