Table 1. Characteristics of the Included RCTs and Cohort Studies.
Source | Country | Cancer type | Biosimilar drug | Reference drug | Patients, No. a | Females, No./males, No. | Primary end point | Study design |
Bevacizumab biosimilar vs bevacizumab | ||||||||
Stroyakovskiy et al,34 2022 | Russia | NSCLC | BCD-021 | Bevacizumab | 357 | 110/230 | ORR | RCT |
Thatcher et al,48 2019 | UK | NSCLC | ABP215 | Bevacizumab | 642 | NA | ORR | RCT |
Reinmuth et al,49 2019 | US | NSCLC | PF-06439535 | Bevacizumab | 719 | 252/467 | ORR | RCT |
Reck et al,46 2020 | Korea | NSCLC | SB8 | Bevacizumab | 763 | 255/508 | ORR | RCT |
Yang et al,47 2019 | China | NSCLC | IBI305 | Bevacizumab | 450 | 162/279 | ORR | RCT |
Trukhin et al,39 2021 | Ukraine | NSCLC | MB02 | Bevacizumab | 627 | 244/383 | ORR | RCT |
Rezvani et al,45 2020 | Iran | MCRC | BE1040V | Bevacizumab | 126 | 35/91 | PFS | RCT |
Qin et al,43 2021 | China | MCRC | HLX04 | Bevacizumab | 677 | 271/404 | PFS | RCT |
Shi et al,42 2021 | China | NSCLC | LY01008 | Bevacizumab | 649 | 237/352 | ORR | RCT |
Chu et al,44 2021 | China | NSCLC | QL1101 | Bevacizumab | 535 | 217/318 | ORR | RCT |
Hengrui (sponsor),36 2022 | China | NSCLC | BP102 | Bevacizumab | 517 | NA | ORR | RCT |
Wan et al,38 2021 | China | NSCLC | MIL60 | Bevacizumab | 517 | 183/325 | ORR | RCT |
Syrigos et al,40 2021 | UK | NSCLC | FKB238 | Bevacizumab | 731 | 248/483 | ORR | RCT |
Kim et al,35 2021 | US | NSCLC | BI695502 | Bevacizumab | 671 | 246/417 | ORR | RCT |
Socinski et al,41 2021 | US | NSCLC | MYL-14020 | Bevacizumab | 671 | 247/424 | ORR | RCT |
Chen et al,37 2022 | China | NSCLC | BAT1706 | Bevacizumab | 651 | NA | ORR | RCT |
Lu et al,32 2023 | China | NSCLC | Table 008 | Bevacizumab | 549 | 194/457 | ORR | RCT |
Verschraegen et al,33 2022 | US | NSCLC | CT-P16 | Bevacizumab | 689 | 149/397 | ORR | RCT |
Zhao et al,71 2023 | China | DLBCL | QL1101 | Bevacizumab | 946 | 413/533 | ORR | Cohort study |
Rituximab biosimilar vs rituximab | ||||||||
Kaplanov et al,61 2014 | Russia | FL | BCD-020 | Rituximab | 92 | NA | ORR | RCT |
Toogeh et al,57 2018 | Iran | CLL | Zytux | Rituximab | 70 | 13/57 | ORR | RCT |
Jurczak et al,60 2017 | Poland | FL | GP2013 | Rituximab | 629 | 350/277 | ORR | RCT |
Kim et al,59 2017 | Korea | FL | CT-P10 | Rituximab | 140 | 77/63 | ORR | RCT |
Ogura et al,58 2018 | Japan | FL | CT-P10 | Rituximab | 258 | 145/123 | ORR | RCT |
Poddubnaya et al,54 2020 | Russia | Indolent NHL | BCD-020 | Rituximab | 174 | 90/84 | ORR | RCT |
Candelaria et al,56 2019 | Mexico | DLBCL | RTXM83 | Rituximab | 272 | 117/155 | ORR | RCT |
Sharman et al,53 2020 | US | FL | PF-05280586 | Rituximab | 394 | 216/178 | ORR | RCT |
Niederwieser et al,55 2020 | Germany | FL | ABP 798 | Rituximab | 256 | 126/130 | ORR | RCT |
Archigen (sponsor),51 2020 | Korea | FL | SAIT101 | Rituximab | 315 | 174/141 | ORR | RCT |
Shi et al,52 2020 | China | DLBCL | HLX01 | Rituximab | 407 | 182/220 | ORR | RCT |
Song et al,50 2021 | China | DLBCL | IBI301 | Rituximab | 419 | 202/214 | ORR | RCT |
Roy et al,74 2013 | India | DLBCL | Reditux | Rituximab | 173 | 51/112 | NA | Cohort study |
Bankar et al,73 2020 | India | DLBCL | Reditux | Rituximab | 152 | 41/111 | NA | Cohort study |
Deng et al,72 2022 | China | DLBCL | HLX-01 | Rituximab | 33 | 13/20 | NA | Cohort study |
Trastuzumab biosimilar vs trastuzumab | ||||||||
Stebbing et al,69 2017 | UK | Early BC | CT-P6 | Trastuzumab | 549 | 549/0 | PCR | RCT |
Rugo et al,70 2017 | US | MBC | MYL-14010 | Trastuzumab | 500 | 500/0 | ORR | RCT |
von Minckwitz et al,67 2018 | Germany | Early BC | ABP 980 | Trastuzumab | 725 | 725/0 | PCR | RCT |
Pivot et al,68 2018 | France | Early BC | SB3 | Trastuzumab | 875 | 875/0 | PCR | RCT |
Pegram et al,66 2019 | US | MBC | PF-05280014 | Trastuzumab | 707 | 707/0 | ORR | RCT |
Pivot et al,62 2022 | France | Early BC | HD201 | Trastuzumab | 502 | 502/0 | PCR | RCT |
Alexeev et al,65 2020 | Russia | MBC | BCD-022 | Trastuzumab | 225 | 225/0 | ORR | RCT |
Xu et al,64 2021 | China | MBC | HLX02 | Trastuzumab | 649 | 649/0 | ORR | RCT |
Nodehi et al,63 2022 | Iran | Early BC | TA4415V | Trastuzumab | 92 | 92/0 | PCR | RCT |
Bae et al,80 2021 | Korea | Early and metastatic BC | CT-P6 | Trastuzumab | 254 | NA | PCR and PFS | Cohort study |
Park et al,77 2022 | Korea | Advanced GC | CT-P6 | Trastuzumab | 102 | 14/88 | NA | Cohort study |
Yang et al,76 2022 | Canada | Early BC | MYL-1401O | Trastuzumab | 136 | NA | PCR | Cohort study |
Bernat-Peguera et al,79 2022 | Spain | Early BC | CT-P6 | Trastuzumab | 44 | NA | NA | Cohort study |
Eser et al,75 2023 | Turkey | Early and metastatic BC | MYL-1401O | Trastuzumab | 53 | NA | PCR and PFS | Cohort study |
Liu et al,78 2022 | China | Early BC | HLX02 | Trastuzumab | 105 | 105/0 | NA | Cohort study |
Abbreviations: BC, breast cancer; CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; GC, gastric cancer; MBC, metastatic breast cancer; MCRC, metastatic colorectal cancer; NA, not available; NHL, non-Hodgkin lymphoma; NSCLC, non–small cell lung cancer; ORR, objective response rate; PCR, pathologic complete remission; PFS, progression-free survival; RCT, randomized clinical trial.
The number of patients was defined as the number of patients at randomization. The combined number of males and females of some studies does not equal the patient total because data on sex were missing for some patients.