Table 2. Comparison of Pivotal Clinical Trials Used to Support Approval of Cancer Biosimilars by the FDA, EMA, PMDA, and NMPA.
| Characteristic | FDA | EMA | PMDA | NMPA |
|---|---|---|---|---|
| Bevacizumab biosimilar vs bevacizumab | ||||
| Products, No. | 4 | 7 | 4 | 8 |
| Pivotal trials, No. | 4 | 7 | 4 | 8 |
| Sample size, median (IQR), No. | 666 (638-696) | 689 (657-725) | 666 (638-696) | 542 (517-650) |
| Equivalence, No. | 4/4 | 7/7 | 4/4 | 8/8 |
| Cancer type | ||||
| NSCLC, No./total No. | 4/4 | 7/7 | 4/4 | 7/8 |
| MCRC, No./total No. | 0/4 | 0/7 | 0/4 | 1/8 |
| Rituximab biosimilar vs rituximab | ||||
| Products, No. | 3 | 3 | 2 | 2 |
| Pivotal trials, No. | 3 | 3 | 2 | 2 |
| Sample size, median (IQR), No. | 258 (257-326) | 256 (198-325) | 512 (452-570) | 413 (410-416) |
| Equivalence, No. | 2/3 | 2/3 | 2/2 | 2/2 |
| Cancer type | ||||
| FL, No./total No. | 3/3 | 3/3 | 2/2 | 0/2 |
| DLBCL, No./total No. | 0/3 | 0/3 | 0/2 | 2/2 |
| Trastuzumab biosimilar vs trastuzumab | ||||
| Products, No. | 5 | 6 | 3 | 1 |
| Pivotal trials, No. | 5 | 6 | 3 | 1 |
| Sample size, median (IQR), No. | 707 (549-725) | 678 (574-721) | 707 (628-716) | 649 (649-649) |
| Equivalence, No. | 5/5 | 6/6 | 3/3 | 1/1 |
| Cancer type | ||||
| Early BC, No./total No. | 3/5 | 3/6 | 2/3 | 0/1 |
| MBC, No./total No. | 2/5 | 3/6 | 1/3 | 1/1 |
Abbreviations: BC, breast cancer; DLBCL, diffuse large B-cell lymphoma; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FL, follicular lymphoma; MBC, metastatic breast cancer; MCRC, metastatic colorectal cancer; NMPA, National Medical Products Administration; NSCLC, non–small cell lung cancer; PMDA, Japanese Pharmaceuticals and Medical Devices Agency.