Table 1. Non-human expression systems used in the production of biotherapeutics approved in the United States and Europe^a,b.

Expression system	Biotherapeutic product	FDA approval	EMA approval
Plant cells	Enzymes
	Taliglucerase alfa	Approved	NA
Insect cells	Vaccines
	Cervical cancer vaccine	Approved	Approved
Bacteria	Monoclonal antibodies
	Certolizumab pegol	Approved	Approved
	Cytokines
	tbo-filgrastim	Approved	NA
	Romiplostim	Approved	Approved
	Enzymes
	Asparaginase Erwinia chrysanthemi	Approved	NA
	Glucarpidase	Approved	NA
	Pegloticase	Approved	Approved
	Collagenase Clostridium histolyticum	Approved	NA
	Peptides	Approved	NA
	Metreleptin
	Therapeutic toxins	Approved	NA
	Incobotulinumtoxin A
	Vaccines
	Meningitis vaccine	Approved	Approved
	Pneumococcal vaccine	Approved	Approved
Yeast	Enzymes
	Ocriplasmin	Approved	Approved
	Peptides
	Albiglutide	Approved	Approved
	Liraglutide	Approved	Approved
	Clotting factors
	Catridecacog	Approved	Approved
Mammalian (non-human) cell lines
CHO	Monoclonal antibodies
	Adalimumab	Approved	Approved
	Alemtuzumab	Approved	NA
	Bevacizumab	Approved	Approved
	Brentuximab vedotin	Approved	Approved
	Denosumab	Approved	Approved
	Golimumab	Approved	Approved
	Ibritumomab tiuxetan	Approved	Approved
	Ipilimumab	Approved	Approved
	Obinutuzumab	Approved	Approved
	Omalizumab	Approved	Approved
	Panitumumab	Approved	Approved
	Pertuzumab	Approved	Approved
	Rituximab	Approved	Approved
	Siltuximab	Approved	Approved
	Tocilizumab	Approved	Approved
	Trastuzumab	Approved	Approved
	Vedolizumab	Approved	Approved
	Ado-trastuzumabemtansine	Approved	Approved
	Ustekinumab	Approved	Approved
	Cytokines
	Darbepoetin alfa	Approved	Approved
	Interferon beta-1a	Approved	Approved
	Epoetin alfa	Approved	Approved
	Epoetin beta	NA	NA
	Epoetin theta	NA	Approved
	Enzymes
	Agalsidase beta	Approved	Approved
	Alglucosidase alfa	Approved	Approved
	Alteplase	Approved	Approved
	Elosulfase alfa	Approved	NA
	GalNAc 4-sulfatase	Approved	NA
	Human DNase	Approved	Approved
	Hyaluronidase	Approved	NA
	Imiglucerase	Approved	NA
	Laronidase	Approved	NA
	Tenecteplase	Approved	Approved
	Fc-fusion proteins
	Abatacept	Approved	Approved
	Aflibercept	Approved	Approved
	Alefacept	Approved	Approved
	Belatacept	Approved	Approved
	Etanercept	Approved	NA
	Rilonacept	Approved	Approved
	Ziv-aflibercept	Approved	Approved
	Hormones
	Choriogonadotropin alfa	Approved	NA
	Follitropin alfa	Approved	Approved
	Follitropin beta	Approved	Approved
	Luteinizing hormone	Approved	Approved
	Osteogenic protein-1	Approved	Approved
	Thyrotropin alfa	Approved	Approved
	Clotting factors
	Factor VIII	Approved	Approved
	Factor IX	Approved	Approved
NS0	Monoclonal antibodies
	Belimumab	Approved	Approved
	Natalizumab	Approved	Approved
	Ofatumumab	Approved	Approved
	Palivizumab	Approved	Approved
	Ramucirumab	Approved	NA
Sp2/0	Monoclonal antibodies
	Abciximab	Approved	NA
	Basiliximab	Approved	Approved
	Canakinumab	Approved	Approved
	Cetuximab	Approved	Approved
	Infliximab	Approved	Approved
BHK	Clotting factors
	Factor VIIa	Approved	Approved
	Factor VIII	Approved	Approved
Murine C127	Hormones
	Somatropin	Approved	Approved

FDA, US Food and Drug Administration; EMA, European Medicines Agency; NA, not approved; CHO, Chinese hamster ovary; BHK, baby hamster kidney.

^aData obtained from publically available resources (October 2014); all approved products may not be included.

^bReferences: (ABSEAMED®, 2012; ACTEMRA®, 2013; ACTILYSE®, 2014; ACTIVASE®, 2012; ADCETRIS®, 2013; ADVATE®, 2014; ALDURAZYME®, 2008; ARANESP®, 2006; ARCALYST™, 2008; ARZERRA®, 2014; AVASTIN®, 2010; AVONEX®, 2007; BENEFIX®, 2012; BENLYSTA®, 2011; CAMPATH®, 2014; CATHFLO® ACTIVASE®, 2010; CEREZYME®, 2010; CERVARIX®, 2012; CIMZIA®, 2013; CIMZIA®, 2014; CYRAMZA®, 2014; ELELYSO™, 2014; ENBREL®, 2010; ENTYVIO®, 2014a,b; EPERZAN™, 2014; Epoetin alfa HEXAL®, 2012; EPORATIO®, 2009; ERBITUX®, 2009; ERWINAZE®, 2011; EYLEA®, 2012; EYLEA®, 2013; FABRAZYME®, 2006; FERTAVID®, 2009; FOLLISTIM®, 2011; GAZYVA™, 2014; GAZYVARO®, 2014; Ghaderi et al., 2012; GONAL-F®, 2010; GRANIX™, 2014; HELIXATE® NexGen, 2010; HERCEPTIN®, 2010; HUMIRA®, 2008; HYLENEX®, 2012; ILARIS®, 2014; JETREA®, 2012; JETREA®, 2013; KADCYLA®, 2013, 2014; KOGENATE® Bayer, 2010; KRYSTEXXA®, 2013; LUMIZYME®, 2010; LUVERIS®, 2005; MABTHERA®, 2008; MENVEO®, 2010; METALYSE®, 2006; MYALEPT™, 2014; MYOZYME®, 2011; NAGLAZYME®, 2005; NOVOSEVEN®, 2006; NOVOTHIRTEEN®, 2012; NPLATE®, 2009; NULOJIX®, 2011; OBIZUR™, 2014; Office of Device Evaluation and Center for Devices and Radiological Health, 2001; OPGENRA®, 2014; ORENCIA®, 2012; OVIDREL®, 2014; OVITRELLE®, 2006; PERJETA®, 2013a,b; PREVNAR®, 2009; PROCRIT®, 2000; PROLIA®, 2010; PULMOZYME®, 2010; RAXIBACUMAB™, 2014; REBIF®, 2008; REFACTO AF®, 2014; REMICADE®, 2009; REOPRO®, 2013; RITUXAN®, 2014; ROACTEMRA®, 2013; SAIZEN®, 1987; SEROSTIM®, 1987; SIMPONI®, 2009; SIMULECT®, 2008; Somatropin Biopartners, 2013; STELARA®, 2013; Swiech et al., 2012; SYLVANT®, 2015; SYLVANT™, 2014; SYNAGIS®, 2009; TANZEUM™, 2014; tbo-filgrastim, 2012; THYROGEN®, 2010; TNKASE®, 2011; TRETTEN®, 2014; TYSABRI®, 2011; US Food and Drug Administration, 2010, 2011, 2012, 2013, 2014; Vectibix®, 2014; Victoza®, 2009; VIMIZIM®, 2014a,b; VORAXAZE®, 2012; XEOMIN®, 2014; XIAFLEX®, 2014; XOLAIR®, 2010; XYNTHA®, 2011; YERVOY®, 2011; ZALTRAP®, 2013a,b; ZEVALIN®, 2009).