Product naming, pricing, and market uptake of biosimilars

With a number of patents on biological medicines soon to expire in the US, multiple stakeholders--from policymakers to manufacturers to payers--have been debating the structure of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potentia...

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Veröffentlicht in:GaBI Journal 2015-06, Vol.4 (2), p.64-71
Hauptverfasser: Fuhr, Joseph P, Chandra, Amitabh, Romley, John, Shih, Tiffany, May, Suepattra G, Vanderpuye-Orgle, Jacqueline
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Sprache:eng
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Zusammenfassung:With a number of patents on biological medicines soon to expire in the US, multiple stakeholders--from policymakers to manufacturers to payers--have been debating the structure of regulatory frameworks and in particular, naming conventions for biosimilars. A key area of concern has been the potential impact of naming, and specifically, whether distinguishable non- proprietary names for biosimilars will affect pricing and market uptake of biosimilars. One perspective asserts that because biosimilars are not identical to the originator biological, distinguishable names will allow for identification between biosimilars and originator biologicals. Alternatively, proponents of identical non-proprietary names argue that distinguishable names will hinder market uptake and subsequent consumer benefits. In this review, we analyse the issue of nomenclature in the US biosimilar market from multiple stakeholders' perspectives. We find that multiple factors, including financial incentives, beliefs and behaviours of key stakeholders drive both the entry of biosimilars into the market as well as the extent of its adoption. Keywords: Biosimilar, market uptake, nomenclature, pricing, regulatory issues, specialty pharmaceuticals
ISSN:2033-6403
2033-6772
DOI:10.5639/gabij.2015.0402.015