TABLE 2.

Comparison of biosimilar development criteria of BRICS-TM with ACSS agencies.

Criteria	BRICS-TM agencies	TGA	BRDD	Swissmedic
Biosimilarity	✓	✓	✓	✓
Physicochemical and biological characterisation with in vitro non-clinical PK/PD studies and literature-based clinical performance evaluation, additional in vivo safety data plus confirmatory clinical safety and efficacy trials
Interchangeability decision by:
Agency	Xa	Xb	X	X
Prescriber/physician	✓	X	X	✓
Pharmacist	X	X	✓	X
Comparative quality characterisation
RBP selection
Must be locally authorised	✓	✓	✓	✓
Acceptance of non-locally authorised markets	EU, US, Canada, Australia, Japan, United Kingdom, Germanyc , d , e	EU, US	EU, US, United Kingdom	EU, US
Bridging studies	Not specified	Required	Required	Not required
Analytical specification and method	ICH Q6B (Except Russia MoH, specification same as RBP)	ICH Q6B	ICH Q6B	ICH Q6B
Requirement of comparative stability studies
Mandatory	✓ (ANVISA, Russia MoH, SAHPRA, COFEPRIS)	X	✓	X
Not mandatory	✓ (CDSCO)	✓	X	X
Supportive	✓ (TITCK)	X	X	✓
Non-clinical studies
In vitro studies	✓	✓	✓	✓
In vivo studies	✓	X (if addressed in vitro)	Case-by-case basis	✓ (as per EMA guideline)
Clinical Studies
PK/PD
Combined PK/PD study, fingerprinting approach	✓	✓	Not responded	✓
Requirement of immunogenicity studies	✓ (except Russia MoH)	✓	✓	✓
Comparative clinical efficacy studies
Clinical study design acceptance	✓	✓	✓	✓
Equivalence design	✓ (ANVISA, CDSCO, COFEPRIS)	✓	X	X
Non-inferiority design	✓ (Russia MoH, CDSCO, COFEPRIS)	X	X	X
Local clinical studies

BRICS-TM: ANVISA (Brazil), Russia MoH (Russia), CDSCO (India), NMPA (China), SAHPRA (South Africa), TITCK (Turkey), COFEPRIS (Mexico).

^aRegulated by agency in Russia.

^bDepartment of Health.

^cTITCK.

^dCOFEPRIS except United Kingdom, Germany.

^eNo recognized reference agencies by Brazil, Russia, South Africa.