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The potential for cost savings from the introduction of 'follow-on' versions of protein therapeutics is a major focus of the ongoing debate around the creation of a regulatory pathway for the abbreviated approval of such products. Lanthier and colleagues explore the economic issues relevant to this debate by assessing total sales, product complexity and patent expiry for current protein products.
Specialty pharmaceuticals — drugs prescribed primarily by specialists rather than primary-care physicians — have become an increasingly important part of the global pharmaceutical landscape. Ma and colleagues analyse the key factors influencing the commercial success and failure for specialty pharmaceuticals.
The United States Congress is currently considering legislation to create a regulatory pathway for follow-on biologics. Grabowski discusses the importance of data exclusivity in allowing innovator companies to achieve a return on investment before entry of follow-on competitors, and presents an analysis that provides support for a substantial data exclusivity period.
