AMGEN

AMGEN

approved_indications FDA Approved Biologics and Pending Applications


ABP 654

ustekinumab
ABP 654 Approval Pending

Aimovig®

erenumab-aooe
BL 761077

Amjevita

adalimumab-atto
aBL 761024

Aranesp®

darbepoetin alfa
BL 103951

Avsola®

infliximab-axxq
aBL 761086

Blincyto®

blinatumomab
BL 125557

Enbrel®

etanercept
BL 103795

Epogen® / Procrit®

epoetin alfa
BL 103234

Evenity®

romosozumab-aqqg
BL 761062

Kanjinti®

trastuzumab-anns
aBL 761073

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

Riabni

rituximab-arrx
aBL 761140

Vectibix®

panitumumab
BL 125147

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Amgevita (adalimumab) (Amgen) (November-2020)Avsola (infliximab) (Amgen) (March-2020)Kanjinti® (trastuzumab) (Amgen) (February-2020)Mvasi® (bevacizumab) (Amgen) (October-2018)

Biosimilars Approved In The E.U.

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

Biosimilars Approved In Australia

Amgevita (adalimumab) (Amgen) (November-2017) Kanjinti® (trastuzumab) (Amgen) (May-2019)

approved_indications Inter Partes Review Proceedings


ENBRELIPR2015-01792
IPR2017-01916
IPR2017-02066
SOLIRISIPR2019-00739
IPR2019-00740
IPR2019-00741
HUMIRA / AMJEVITAIPR2015-01514
IPR2015-01517
NEULASTA / STIMUFENDIPR2019-00971
IPR2020-00314
NEUPOGEN / NEULASTAIPR2016-01542
IPR2019-00791
IPR2019-00797
IPR2019-01183
IPR2021-00326
IPR2021-00528
PGR2019-00001
NEUPOGEN / NEULASTA / GRASTOFILIPR2016-01542
NEUPOGEN / NEULASTA / NIVESTYM / NYVEPRIAIPR2021-00528
NEUPOGEN / NEULASTA / RELEUKOIPR2019-00791
IPR2019-00797
PGR2019-00001
NEUPOGEN / NEULASTA / RELEUKO / GRASTOFILPGR2019-00001

approved_indications U.S. Patent Litigations


AMJEVITA1:16-cv-00666 (D. Del.)
1:19-cv-00139 (D. Del.)
BLINCYTO1:22-cv-00035 (D. Del.)
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.)
2:19-cv-11755 (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.)
1:20-cv-00561 (D. Del.)
2:13-cv-04911 (D.N.J.)
2:18-cv-03347 (D.N.J.)
3:14-cv-04741 (N.D. Cal.)
3:19-cv-00977 (N.D. Cal.)
3:19-cv-01374 (S.D. Cal.)
REPATHA1:14-cv-01317 (D. Del.)
1:14-cv-01349 (D. Del.)
1:14-cv-01393 (D. Del.)
1:14-cv-01414 (D. Del.)
2:21-cv-01816 (C.D. Cal.)
AVASTIN / MVASI1:17-cv-00165 (D. Del.)
1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
1:19-cv-00602 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
AVASTIN / MVASI / GENENTECH CABILLY1:17-cv-01407 (D. Del.)
1:17-cv-01471 (D. Del.)
1:19-cv-00602 (D. Del.)
2:17-cv-07349 (C.D. Cal.)
ENBREL / ERELZI2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
ENBREL / ETICOVO2:19-cv-11755 (D.N.J.)
EPOGEN / PROCRIT / RETACRIT1:15-cv-00839 (D. Del.)
GRANIX / NEUPOGEN / NEULASTA2:13-cv-04911 (D.N.J.)
HERCEPTIN / KANJINTI / GENENTECH CABILLY1:18-cv-00924 (D. Del.)
HUMIRA / AMJEVITA1:16-cv-00666 (D. Del.)
NEULASTA / FULPHILA2:17-cv-01235 (W.D. Pa.)
NEULASTA / LAPELGA0:15-cv-61631 (S.D. Fla.)
NEULASTA / NYVEPRIA1:20-cv-00201 (D. Del.)
NEULASTA / UDENYCA1:17-cv-00546 (D. Del.)
56-2017-00493553-CU-BT-VTA (CA Sup. Ct.)
NEULASTA / ZIEXTENZO2:16-cv-01276 (D.N.J.)
3:16-cv-02581 (N.D. Cal.)
3:19-cv-00977 (N.D. Cal.)
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.)
1:20-cv-00561 (D. Del.)
NEUPOGEN / RELEUKO2:18-cv-03347 (D.N.J.)
NEUPOGEN / TX-013:19-cv-01374 (S.D. Cal.)
NEUPOGEN / ZARXIO3:14-cv-04741 (N.D. Cal.)
3:19-cv-00977 (N.D. Cal.)
NEUPOGEN / ZARXIO / NEULASTA / ZIEXTENZO3:19-cv-00977 (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.)
STELARA / ABP 6541:22-cv-01549 (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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