Table 1.
Marketed therapeutic monoclonal antibody products
| Brand name (INN) | Original BLA/MAA Applicant | Company Reporting US Sales | Company Reporting EU Sales | Year of First Approval | 2013 Global Sales ($M)a |
|---|---|---|---|---|---|
| Abthrax (raxibacumab) | Human Genome Sciences | GlaxoSmithKline | N/Ab | 2012 | 23 |
| Actemra (tocilizumab) | Roche | Roche | Roche | 2009 | 1,119 |
| Adcetrisc (brentuximab vedotin) | Seattle Genetics | Seattle Genetics | Takeda Pharmaceutical Co. | 2011 | 253 |
| AlprolIXd (Factor IX Fc fusion protein) | Biogen Idec | Biogen Idec | N/A | 2014 | NoMe |
| Arcalystf (rilonacept) | Regeneron Pharmaceuticals | Regeneron Pharmaceuticals | N/A | 2008 | 17 |
| Arzerra (ofatumumab) | GlaxoSmithKline | GlaxoSmithKline | GlaxoSmithKline | 2009 | 117 |
| Avastin (bevacizumab) | Genentech | Roche | Roche | 2004 | 6,748 |
| Benlysta (belimumab) | Human Genome Sciences | GlaxoSmithKline | GlaxoSmithKline | 2011 | 228 |
| Cimziag (certolizumab pegol) | UCB | UCB | UCB | 2008 | 789 |
| Cyramza (ramucirumab) | Eli Lilly and Co. | Eli Lilly and Co. | N/A | 2014 | NoMe |
| Eloctateh (Factor VIII Fc fusion protein) | Biogen Idec | Biogen Idec | N/A | 2014 | NoMe |
| Enbreli (etanercept) | Immunex | Amgen | Pfizer | 1998 | 8,325 |
| Entyvio (vedolizumab) | Takeda Pharmaceuticals U.S.A., Inc | Takeda Pharmaceutical Co. | Takeda Pharmaceutical Co. | 2014 | NoMe |
| Erbitux (cetuximab) | ImClone Systems | Bristol-Myers Squibb | Merck KGaA | 2004 | 1,926 |
| Eyleaj (aflibercept) | Regeneron Pharmaceuticals | Regeneron Pharmaceuticals | Bayer Healthcare Pharmaceuticals | 2011 | 1,851 |
| Gazyva (obinutuzumab) | Genentech | Roche | Roche | 2013 | 3 |
| Herceptin (trastuzumab) | Genentech | Roche | Roche | 1998 | 6,559 |
| Humira (adalimumab) | Abbott Laboratories | AbbVie | AbbVie | 2002 | 10,659 |
| Ilaris (canakinumab) | Novartis Pharmaceuticals | Novartis Pharmaceuticals | Novartis Pharmaceuticals | 2009 | 119 |
| Inflectrak l (infliximab [biosimilar]) | Hospira | N/A | Hospira | 2013 | <1m |
| Kadcylan (ado-trastuzumab emtansine) | Genentech | Roche | Roche | 2013 | 252 |
| Keytruda (pembrolizumab) | Merck & Co. | Merck & Co. | N/A | 2014 | NoMe |
| Lemtrada (alemtuzumab) | Genzyme Therapeutics | N/A | Sanofi | 2013 | 3 |
| Lucentiso (ranibizumab) | Genentech | Roche | Novartis Pharmaceuticals | 2006 | 4,205 |
| Nplatep (romiplostim) | Amgen | Amgen | Amgen | 2008 | 427 |
| Nulojixq (belatacept) | Bristol-Myers Squibb | Bristol-Myers Squibb | Bristol-Myers Squibb | 2011 | 26 |
| Orenciar (abatacept) | Bristol-Myers Squibb | Bristol-Myers Squibb | Bristol-Myers Squibb | 2005 | 1,444 |
| Perjeta(pertuzumab) | Genentech | Roche | Roche | 2012 | 352 |
| Prolias (denosumab) | Amgen | Amgen | GlaxoSmithKline | 2011 | 824 |
| Remicade (infliximab) | Centocor | Johnson & Johnson | Merck & Co. | 1998 | 8,944 |
| Removabt (catumaxomab) | Fresenius Biotech | N/A | NeoPharm Group | 2009 | 5 |
| Remsimak l (infliximab [biosimilar]) | Celltrion | N/A | Celltrion | 2013 | <1m |
| ReoProu (abciximab) | Centocor | Lilly | N/A | 1994 | 127 |
| Rituxan (rituximab) | Genentech | Roche | Roche | 1997 | 7,500 |
| Simponi/ Simponi Aria (golimumab) | Centocor Ortho Biotech | Johnson & Johnson | Merck & Co. | 2009 | 1,432 |
| Simulect (basiliximab) | Novartis Pharmaceuticals | Novartis Pharmaceuticals | Novartis Pharmaceuticals | 1998 | 30v |
| Soliris (eculizumab) | Alexion Pharmaceuticals | Alexion Pharmaceuticals | Alexion Pharmaceuticals | 2007 | 1,551 |
| Stelara (ustekinumab) | Janssen-Cilag International | Johnson & Johnson | Johnson & Johnson | 2009 | 1,504 |
| Sylvant (siltuximab) | Janssen Biotech | Johnson & Johnson | Johnson & Johnson | 2014 | NoMe |
| Synagis (palivizumab) | Abbott Laboratories | AstraZeneca | Abbvie | 1998 | 1,887 |
| Tysabri (natalizumab) | Biogen Idec | Biogen Idec | Biogen Idec | 2004 | 1,527 |
| Vectibix (panitumumab) | Amgen | Amgen | Amgen | 2006 | 389 |
| Xgevas (denosumab) | Amgen | Amgen | Amgen | 2010 | 1,030 |
| Xolair (omalizumab) | Genentech | Roche | Novartis | 2003 | 1,465 |
| Yervoy (ipilimumab) | Bristol-Myers Squibb | Bristol-Myers Squibb | Bristol-Myers Squibb | 2011 | 960 |
| Zaltrapw (ziv-aflibercept) | Sanofi Aventis | Sanofi | Sanofi | 2012 | 70 |
| Zevalinx (ibritumomab tiuxetan) | IDEC Pharmaceuticals | Spectrum Pharmaceuticals | Spectrum Pharmaceuticals | 2002 | 29 |
a Sales information obtained from company annual reports and other publically available sources.
b N/A denote product not available in this region.
c Antibody-Drug Conjugate, MMAE.
d Fc Fusion Protein, Fc-Factor IX.
e Product approval in 2014; no sales in 2013.
f Fc Fusion Protein, Fc-IL1R.
g Fab Conjugate, PEG (produced by microbial fermentation).
h Fc Fusion Protein, Fc-Factor VIII.
i Fc Fusion Protein, Fc-TNFR (p75).
j Fc Fusion Protein, Fc-VEGFR (1,2).
k Biosimilar Antibody, Remicade Originator.
l Inflectra and Remsima are considered as two individual products; see text.
m Product approval in late 2013; no annual sales disclosed, bioTRAK® estimate of global sales.
n Antibody-Drug Conjugate, DM1.
o Fab (produced by microbial fermentation).
p Fc Fusion Protein, Fc-TPO-R binding peptide (produced by microbial fermentation).
q Fc Fusion Protein, Fc-CTLA-4 with amino acid substitutions.
r Fc Fusion Protein, Fc-CTLA-4.
s Prolia and Xgeva are considered as two individual products even though they contain the same bulk monoclonal antibody; see text.
t Bispecific, Tri-functional Antibody.
u Sales data not disclosed, small patient market, bioTRAK® estimate of global sales.
v Fab, produced by papain digestion of full length monoclonal antibody.
w Fc Fusion Protein, Fc-VEGFR.
x Antibody Conjugate, Y-90.