A. A randomized clincial trial of similar in design to that for approval biosimilar Is interchangeable in one or more indications for which the reference product is licensed based on the totality of evidence and with scientific justification. B. A dedicated switching study and postmarketing monitoring. C. If administered more than once, the risk of alternating or switching is not greater than using reference product. D. Anticipated to produce the same clinical result in any given patient.

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. The naming convention for biosimilar products. B. Failure to demonstrate that a biosimilar is biobetter in one or more characteristics than its reference product. C. The perception that biosimilars are “knock offs”. D. Lack of data to allow substitution.

A. Reducing the per capita cost of a biosimilar. B. Collaboration between pharmacists and physicians in the formulary process. C. Understanding and addressing concerns about biosimilars expressed by medical staff and/or patients. D. The naming convention for biosimilars.