A. The biosimilar must demonstrate comparable efficacy and safety to the reference biologic within at least one approved indication. B. The biosimilar must show highly similar structural similarity to a reference biologic, with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. C. The biosimilar must demonstrate absence of clinically meaningful differences from the reference biologic. D. Demonstrate that it is highly similar to the reference biologic with no clinically meaningful differences.

A. Once approved by FDA, a biosimilar can be substituted by a pharmacist for the branded product. B. Bevacizumab-awwb is the only biosimilar biologic than has been designated by FDA as interchangeable. C. FDA requires a description of the pharmacovigilance system and a risk management plan as part of the biosimilar application for approval. D. Any biological product under consideration for substitution must first be approved by FDA as "interchangeable.”

A. Rigorous analytical tests did not detect any meaningful differences between the biosimilar and its reference product. B. A comparative clinical study showed no meaningful differences between the biosimilar and its reference product. C. Human PK/PD data, and clinical immunogenicity assessment showed no residual uncertainties. D. A comparative clinical study in an adequately sensitive population did not provide any evidence of residual uncertainty.

A. Extrapolation B. Interchangeability and substitution C. Timing of a switch to a biosimilar D. Avoiding combination therapy