FDA Approved Biologics and Pending Applications
asparaginase
BL 101063
follitropin alfa/beta
BL 021211
pembrolizumab
BL 125514
insulin glargine
Lusduna Nexvue Tentatively Approved
trastuzumab-dttb
aBL 761100
chorionic gonadotropin
BL 017692
infliximab-abda
BL 761054
sotatercept-csrk
BL 761363
bezlotoxumab
BL 761046
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)Remaloce (infliximab) (Samsung Bioepis / Merck) (December-2015)
Inter Partes Review Proceedings
GENENTECH CABILLYIPR2016-00710IPR2016-01373IPR2017-00047KEYTRUDAIPR2016-01217IPR2016-01218IPR2016-01219IPR2016-01221IPR2024-00240IPR2024-00622IPR2024-00623IPR2024-00624IPR2024-00625IPR2024-00647IPR2024-00648IPR2024-00649IPR2024-00650PGR2021-00036PGR2021-00039OPDIVO / KEYTRUDAIPR2016-01217IPR2016-01218IPR2016-01219IPR2016-01221
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.)1:22-cv-03059 (D. Md.)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.)