. 2023 Oct 12;6(10):e2337348. doi: 10.1001/jamanetworkopen.2023.37348

Table 3. Summary Results of Primary Efficacy End Points Used to Support Pivotal Trials for FDA, EMA, PMDA, and NMPA Approval of Cancer Biosimilars.

Outcome and cancer subgroup	RCTs, No.	Sample size, No.		Test of heterogeneity		RR (95% CI)^a	P value
Outcome and cancer subgroup	RCTs, No.	Biosimilar	Reference drug	I², %	P value	RR (95% CI)^a	P value
Bevacizumab biosimilar vs bevacizumab
NSCLC ORR
FDA	4	1343	1334	0	.78	0.97 (0.89-1.06)	.48
EMA	7	2423	2419	0	.65	0.99 (0.93-1.05)	.64
PMDA	4	1343	1334	0	.76	0.97 (0.89-1.06)	.48
NMPA	7	1938	1930	0	.60	0.99 (0.93-1.05)	.63
CRC PFS
NMPA	1	340	337	NA	NA	0.92 (0.78-1.06)	.27
Rituximab biosimilar vs rituximab
FL ORR
FDA	3	552	524	0	.66	1.06 (0.99-1.14)	.12
EMA	3	462	466	0	.70	1.06 (1.00-1.13)	.049
PMDA	2	510	513	17	.27	1.01 (0.95-1.08)	.69
DLBCL
NMPA	2	410	416	52	.15	0.99 (0.93-1.04)	.65
Trastuzumab biosimilar vs trastuzumab
Early BC PCR
FDA	3	1072	1077	68	.04	1.11 (0.94-1.32)	.21
EMA	3	1072	1077	68	.04	1.11 (0.94-1.32)	.21
PMDA	2	635	639	74	.05	1.05 (0.83-1.34)	.68
MBC ORR
FDA	2	602	605	64	.09	1.01 (0.87-1.16)	.93
EMA	3	926	930	28	.25	1.00 (0.93-1.08)	.99
PMDA	1	352	355	NA	NA	0.94 (0.84-1.05)	.27
NMPA	1	324	325	NA	NA	1.00 (0.91-1.11)	.98

Abbreviations: BC, breast cancer; CRC, colorectal cancer; DLBCL, diffuse large B-cell lymphoma; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FL, follicular lymphoma; MBC, metastatic breast cancer; NA, not available; NMPA, National Medical Products Administration; NSCLC, non–small cell lung cancer; ORR, objective response rate; PCR, pathologic complete remission; PFS, progression-free survival; PMDA, Japan Pharmaceuticals and Medical Devices Agency; RCT, randomized clinical trial; RR, risk ratio.

^{^a}

Results of meta-analysis.