Table 2.

Comparison of main features of Brazilian regulation on biosimilars in relation to the European Medicines Agency, US Food and Drug Administration and World Health Organization.

	Brazil	Europe	USA	WHO
Denomination	Produto biológico *	Biosimilar	Biosimilar	Similar biotherapeutic product
Regulatory pathways	Two pathways: comparability and individual (standalone)	Only by comparability
Primary source of regulation	Resolution of board of directors of ANVISA	EMA guidelines were developed after directives approved by European parliament	FDA guidelines were developed after the BPCI Act passed by American Congress	Approved by expert committee
Biosimilarity	Not defined and not required in the individual pathway	Defined and required as precondition for approval
Reference Product	Not required in the individual pathway	Defined and required in all cases
Nonclinical and clinical studies	In the individual pathway, a unique comparator is not required	Detailed guidance Same reference product is required in all comparisons
Interchangeability	Not regulated	Regulated by member states	Defined by law (BPCI Act) based on scientific criteria	Not regulated
Extrapolation among indications	Possible with defined criteria
Nonproprietary names	No rule; same names for reference and all biosimilars	Possible disambiguation through manufacturer identification	Final rules in place with core name and suffix	Biologic Qualifier with suffix

^*In the Brazilian regulation the expression produto biológico refers to the whole class or only to the copies, depending on the context.

ANVISA, National Health Surveillance Agency in Brazil; BPCI Act, Biologics Price Competition and Innovation Act, EMA, European Medicines Agency; FDA, US Food and Drug Administration; WHO, World Health Organization.