Table 2.
Clinical studies of potential biosimilars to bevacizumab
| Biosimilar | Manufacturer | Design | Population (N) | Dose of bevacizumab | Primary endpoints (time frame) | Current status | Reference and/or NCT number* |
|---|---|---|---|---|---|---|---|
| ABP 215 | Amgen | Randomized, 3-arm, single-dose study to assess PK of ABP 215, BEV-EU, and BEV-US | Healthy adult males (NR) | NR | AUC0–inf; Cmax (NR) | Completed. Similar PK profiles | Markus et al. [61] |
| Randomized, double-blind study to compare safety and efficacy of ABP 215 and BEV | Advanced non-squamous NSCLC (642) | 15 mg/kg Q3W | ORR (19 weeks) | Completed. Similar efficacy, safety, and immunogenicity profiles | Thatcher et al. [62, 63] NCT01966003 | ||
| BCD-021 | Biocad | PK sub-study of randomized, double-blind study | Advanced non-squamous NSCLC (28) | 15 mg/kg | AUCtau (504 h) | Completed. Similar PK and safety profiles | Orlov et al. [64] NCT01763645 |
| Randomized, double-blind study to compare safety and efficacy of BCD-021 and BEV | Advanced non-squamous NSCLC (138) | 15 mg/kg Q3W | ORR (127 days) | Completed. Similar efficacy, safety, and immunogenicity profiles | Filon et al. [65] NCT01763645 |
||
| BEVZ92 | mAbxience | Randomized, open-label study to compare PK and safety of BEVZ92 and BEV | mCRC (142) | 5 mg/kg Q2W | PK profile (15 weeks) | Ongoing (primary completion datea Oct 2015) | NCT02069704 |
| BI 695502 | Boehringer Ingelheim | Randomized, single-blind, single-dose, 3-arm study to compare PK and safety of BI 695502, BEV-EU, and BEV-US | Healthy male volunteers (91) | 1 mg/kg | AUC0–inf (99 days) | Completed. Similar PK and safety profiles | Hettema et al. [66] NCT01608087 |
| Randomized, double-blind study to compare efficacy and safety of BI 695502 and BEV | Advanced non-squamous NSCLC (est. 660) | NR | ORR (18 weeks) | Recruiting (est. primary completion datea Aug 2017) | NCT02272413 | ||
| Single-arm, open-label study to evaluate safety and efficacy | mCRC (est. 120) | NR | Selected AEs (16.5 months) | Recruiting (est. primary completion datea Nov 2018) | NCT02776683 | ||
| CBT124 | Cipla BioTec | Randomized, double-blind, single-dose, 3-arm study to compare PK and safety of CBT124, BEV-EU, and BEV-US | Healthy male volunteers (est. 150) | 1 mg/kg | AUC0–inf (95 days) | Recruiting (est. primary completion datea Oct 2016) | NCT02747823 |
| Randomized, double-blind study to compare efficacy, safety, and immunogenicity of CBT124 and BEV-EU | Advanced non-squamous NSCLC (est. 200) | 15 mg/kg Q3W | ORR (19 weeks) | Planned (est. primary completion datea Dec 2017) | NCT02879097 | ||
| FKB238 | Centus Biotherapeutics | Randomized, double-blind study to compare safety and efficacy of FKB238 and BEV | Advanced/recurrent non-squamous NSCLC (est. 730) | 15 mg/kg Q3W | ORR (12 months) | Recruiting (est. completion datea Jun 2019) | NCT02810457 |
| PF-06439535 | Pfizer | Randomized, double-blind, single-dose, 3-arm study to compare PK of PF-06439535, BEV-EU, and BEV-US | Healthy male volunteers (102) | 5 mg/kg | Cmax; AUCtau; AUC0–inf (71 days) | Completed. Similar PK and safety profiles |
Knight et al. [67] NCT02031991 |
| Randomized, double-blind study to compare safety and efficacy of PF-06439535 and BEV-EU | Advanced non-squamous NSCLC (est. 710) | 15 mg/kg Q3W | ORR (19 weeks) | Recruiting (est. primary completion datea May 2017) | NCT02364999 | ||
| SB8 | Samsung Bioepis | Randomized, double-blind, single-dose, 3-arm study to compare PK, safety, and immunogenicity of SB8, BEV-EU, and BEV-US | Healthy male volunteers (119) | 3 mg/kg | Cmax; AUCtau; AUC0–inf (85 days) | Completed | NCT02453672 |
| Randomized, double-blind study to compare safety, efficacy, PK, and immunogenicity of SB8 and BEV-EU | Advanced non-squamous NSCLC (est. 678) | 15 mg/kg Q3W | ORR (24 weeks) | Recruiting (est. primary completion datea Jun 2018) | NCT02754882 |
Table last updated in May 2017
AEs adverse events, AUC 0–inf area under the curve from time zero to extrapolated infinite time, AUC tau area under the curve from time zero to last quantifiable concentration, BEV bevacizumab, BEV-EU bevacizumab sourced from the European Union, BEV-US bevacizumab sourced from the United States, C max maximum serum concentration; est., estimated, mCRC metastatic colorectal cancer, NCT National Clinical Trial, NR not reported, NSCLC non–small-cell lung cancer, ORR objective/overall response rate, PK pharmacokinetics, Q2W every 2 weeks, Q3W every 3 weeks
*Biosimilars included are those with trials registered at ClinicalTrials.gov; other potential biosimilars may also be in development
aPrimary completion date refers to date of final data collection for primary outcome measure