How can biosimilars change the trajectory of breast cancer therapy?

Figures & data

Table 1. The clinical landscape of drug development and regulatory status of approved and proposed biosimilars.

Regulatorystatus ^a	Drug	Interventions	Setting	Gender	Sponsor/Collaborators	NCT Number; phase of development
Proposed biosimilars	AryoTrust	AnC-> T + D	(Neo)A	Female	AryoGen Pharmed Co.	NCT03425656 [TRA.ARY.RS.95 (III)]; 3
	SIBP-01 (CN-Trastuzumab)	CarboD + T	(Neo)A	Female	Shanghai Institute Of Biological Products|Fudan University	NCT03989037 [SIBP-01-3]; 3
	TX05	AnC-> T + D	(Neo)A	Female	Tanvex BioPharma USA, Inc.	NCT03556358 [TX05-03]; 3
	HLX02^b	T + D	ABC	All	Shanghai Henlius Biotech	NCT03084237 [HLX02-BC01|2016-000206-10]; 3
	BCD-022	T + D	ABC	Female	Biocad	NCT01764022 [BCD-022-02]; 3
	ALT02	T	NA^a	Male (healthy volunteer)	Alteogen, Inc.|Cristália Produtos Químicos Farmacêuticos Ltda	NCT03242239 [ALT02]; 1
	HD201	AnC-> T + D	(Neo)A	Female	Prestige Biopharma Pte Ltd	NCT03013504 [TROIKA]; 3
Approved biosimilars	ABP 980	AnC-> T + D	(Neo)A	Female	Amgen/Actavis Inc.	NCT01901146 [Lilac]; 3
	CT-P6	FAnC -> T + D	(Neo)A	Female	Celltrion/Nippon Kayaku Co., Ltd.	NCT02162667; 3
	MYL-1401O	T + D	ABC	All	Mylan Inc./Mylan GmbH	NCT02472964 [HERiTAge]; 3
	PF-05280014	A: T + D; B: CarboD + T	A: ABD; B: (Neo)A	All	Pfizer	A: NCT01989676 [REFLECTIONS B327-02]; 3 B: NCT02187744 [REFLECTIONS B327-04]; 3
	SB3	FAnC -> T + D	(Neo)A	Female	Samsung Bioepis Co., Ltd.	NCT02149524; 3

aAs per November 2019. ^bthe phase 3 trial met the primary endpoint and the registration has been requested for human use.

An, anthracycline; C, cyclophosphamide; T, trastuzumab or trastuzumab biosimilar; D, taxane; (Neo)A, neoadjuvant or adjuvant regimen; Carbo, carboplatin; ABC, advanced breast cancer; NA, not applicable; F, 5-fluorouracil.

Figure 1. The global distribution of institutions involved in the clinical development of proposed (a) or approved (b) biosimilars of trastuzumab.