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Avoiding No Man's Land: Potential Unintended Consequences of Follow-On Biologics
Still, the essential debate encompasses two broad issues: patient safety and industry economics. This paper from Deloitte explores what will constitute threshold biosimilarity? The definition of biosimilarity is likely to involve standards regarding the degree to which a follow-on biologic has the same mechanism of action (i.e., if it targets the same molecular disease regulator) as the original drug, and if it passes efficacy and safety screens.