A. All biosimilars are interchangeable with their reference product and each other B. The molecular composition of biologics are impossible to fully characterize C. The manufacturing process for biologics significantly impacts stability, structure, and immunogenicity D. A biosimilar is a “copy” of a originator product with determined similarity in physicochemical properties and is unlikely to have “clinically meaningful” differences with the originator product

A. The Public Health Service Act (PHSA) created an abbreviated FDA approval pathway for biosimilars B. Like the EMA, the FDA has issued specific guidance on the development of biosimilar insulins C. The EMA requires immunogenicity studies of at least 12 months for biosimilar insulins D. The FDA recognizes only 1 category of biosimilar drugs

A. All biosimilar insulins will be designated as being interchangeable to the originator insulin B. It has been determined that post-marketing pharmacovigilance is optional C. It has been decided that biosimilar insulins will have the same name as the originator product D. Only FDA designated interchangeable insulins are appropriate to be substituted for the reference product without the intervention of the prescribing healthcare provider

A. Ensure a process is in place to trace adverse events for the specific product B. Ensure that automatic substitution is in place for the biosimilar C. Ensure that the biosimilar is maximally used to improve pharmacy margins D. None of the above