MERCK

MERCK

approved_indications FDA Approved Biologics and Pending Applications


Elspar®

asparaginase
BL 101063

Keytruda®

pembrolizumab
BL 125514

Lusduna Nexvue

insulin glargine
Lusduna Nexvue Tentatively Approved

Renflexis

infliximab-abda
BL 761054

Zinplava®

bezlotoxumab
BL 761046

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Brenzys (etanercept) (Samsung Bioepis / Merck Canada) (August/September-2016)

Biosimilars Approved In The E.U.

Lusduna (insulin glargine recombinant) (Merck) (January-2017)

Biosimilars Approved In Australia

Renflexis (infliximab) (Samsung Bioepis / Merck) (November-2016)

Biosimilars Approved In South Korea

Davictrel (HD203) (etanercept) (Hanwha Chemical / Merck) (November-2014)Renflexis (infliximab) (Samsung Bioepis / Merck) (December-2015)

approved_indications Inter Partes Review Proceedings


GENENTECH CABILLYIPR2016-00710
IPR2016-01373
IPR2017-00047
OPDIVO / KEYTRUDAIPR2016-01217
IPR2016-01218
IPR2016-01219
IPR2016-01221

approved_indications U.S. Patent Litigations


KEYTRUDA1:14-cv-01131 (D. Del.)
1:15-cv-00560 (D. Del.)
1:15-cv-00572 (D. Del.)
1:16-cv-00407 (D.N.J.)
3:15-cv-00536 (D. Nev.)
LANTUS / LANTUS SOLOSTAR / LUSDUNA NEXVUE1:16-cv-00812 (D. Del.)
2:17-cv-05914 (D.N.J.)
OPDIVO / BAVENCIO1:17-cv-01029 (D. Del.)
OPDIVO / KEYTRUDA1:14-cv-01131 (D. Del.)
1:15-cv-00560 (D. Del.)
1:15-cv-00572 (D. Del.)

related articles Related News Articles


Venable Fitzpatrick’s BiologicsHQ Monthly Injection – October 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 12, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017

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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