Table 3.

Major clinical and regulatory concerns of healthcare professionals related to biosimilars.

Clinical and Regulatory Concerns	Definitions
Interchangeability concepts	Europe: Interchangeability: switching and substitution describes the process of transitioning from the originator to biosimilar and back and forth or between two biosimilars. Interchangeability comprises switching (a transition implemented by the clinician) and automatic substitution (a transition implemented by the pharmacist without consulting the clinician). United States: Switching describes the process of transitioning from the originator to biosimilar and back and forth or between two biosimilars at the pharmacy level.
Extrapolation concept	A scientific rationale used to describe transferring of the safety and efficacy data from one indication to others, without the need to conduct clinical trials for each indication.
Pharmacovigilance reports	Crucial for the identification of adverse events. Using trade name, international nonproprietary name (INN), and batch number is critical, considering that no two biologics even with the same active substance and from the same batch are identical.