Economic Analysis of Availability of Follow-on Protein Products. Purpose


The purpose of this report is to provide DHHS with an unbiased estimate of potential cost savings from the introduction of FoPPs, considering multiple scenarios for abbreviated regulatory pathways. As described above, three recent analyses of potential cost savings from the introduction of FoPPs have generated divergent findings, due in part to their different scopes of analysis and assumptions. Results from a rigorous analysis with a well-defined scope and realistic assumptions about market behavior may be useful in the context of ongoing policy deliberations. This analysis uses a validated, transparent modeling approach that draws on available data for these products, other rigorous evidence from the literature and focused input from experts on relevant clinical aspects, regulatory policies and practices, pharmacoeconomics, and payment.

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