FDA Approved Biologics and Pending Applications
insulin glargine
aBL 205692
ramucirumab
BL 125477
lebrikizumab-lbkz
BL 761306
galcanezumab-gnlm
BL 761063
cetuximab
BL 125084
teriparatide
NDA 021318
glucagon
BL 20928
insulin lispro recombinant
BL 020563
insulin lispro protamine recombinant; insulin lispro recombinant
BL 021018
insulin lispro protamine recombinant; insulin lispro recombinant
BL 021017
somatropin
BL 019640
insulin human
BL 018780
insulin lispro recombinant
aBL 020563
donanemab-azbt
BL 761248
olaratumab
BL 761038
insulin lispro-aabc
BL 761109
mirikizumab-mrkz
BL 761279
necitumumab
BL 125547
insulin glargine-aglr
aBL 761215
ixekizumab
BL 125521
dulaglutide
BL 125469
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Basaglar (insulin glargine recombinant) (Eli Lilly) (August-2015)
Biosimilars Approved In The E.U.
Abasaglar (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (September-2014)
Biosimilars Approved In Australia
Basaglar (insulin glargine recombinant) (Eli Lilly Australia) (November-2014)
Biosimilars Approved In Japan
Insulin glargine BS (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (December-2014)
Biosimilars Approved In South Korea
Basaglar (insulin glargine) (Eli Lilly November-2015)
U.S. Patent Litigations
ERBITUX2:13-cv-07248 (C.D. Cal.)2:15-cv-06133 (E.D. Pa.)4:13-cv-00919 (N.D. Cal.)FORTEO1:16-cv-00596 (S.D. Ind.)1:21-cv-01922 (S.D. Ind.)1:22-cv-01354 (D. Del.)TALTZ3:18-cv-01518 (S.D. Cal.)AJOVY / EMGALITY1:17-cv-12087 (D. Mass.)1:18-cv-10242 (D. Mass.)1:18-cv-12029 (D. Mass.)1:21-cv-10954 (D. Mass.)ERBITUX / GENENTECH CABILLY2:13-cv-07248 (C.D. Cal.)4:13-cv-00919 (N.D. Cal.)LANTUS / LANTUS SOLOSTAR / BASAGLAR1:14-cv-00113 (D. Del.)1:14-cv-00884 (D. Del.)