Table 3.

RBP selection criteria for six regulatory agencies of BRICS-TM.

Regulatory agency	Selection criteria	Primary source of RBP	Alternate source of RBP	Use of RBP authorised in emerging countries	Criteria of RBP batches	Bridging study requirement	Data Sharing arrangement with other Regulatory agencies
ANVISA	Approved based on full registration dossier with ANVISA	Locally authorised RBP	First innovator or biosimilar product authorised locally	Not accepted	Multiple batches of RBP with varied expiry dates	Not specified	EMA, USFDA, PMDA, MHRA
Russian MoH	Approved based on full registration dossier with Russian Federation	Locally authorised RBP	First innovator product authorised locally	Not accepted	Singe batch of RBP	Not specified	Not specified
CDSCO	Approved based on full registration dossier with CDSCO	Locally authorised RBP	ICH countries	Not accepted	Multiple batches (minimum 3 batches) of RBP with varied expiry dates	Not specified	EMA, USFDA
SAHPRA	Approved based on full registration dossier with SAHPRA	Locally authorised RBP	First innovator product authorised locally	Not accepted	Multiple batches of RBP with varied expiry dates (draft stage; but followed in practise)	Not specified	Not specified
TITCK*	Approved based on full registration dossier with TITCK	Globally authorised RBP	EMA, USFDA, BRDD, TGA, PMDA, MHRA, BfArM	Not accepted	Multiple batches of RBP with varied expiry dates (draft stage; but followed in practise)	Not specified	Not specified
COFEPRIS	Approved based on full registration dossier with COFEPRIS	Locally authorised RBP	EMA, USFDA, TGA, PMDA	Not accepted	Minimum 3 batches	Not specified	No data sharing arrangement and expects full dossier

^*The TITCK agency did not declare acceptable agencies, theoretically all countries are acceptable, extra data can be requested case by case; RBP, Reference Biological Product.