The Market for Biosimilars: Evolution and Policy Options

Adrian Towse

Briefing from Office of Health Economics

Abstract: The authors point out that biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate after patent expiry. Off-patent versions of the originator product, moreover, cannot rely on a simple demonstration of chemical comparability; they are best described as ‘biosimilar’. These differences mean that biosimilar markets will evolve in a more complex way than traditional, small molecule, chemical generics markets. Regulators will need clinical trial evidence of efficacy and safety before approval. Clinicians will require “patient safety year” (PSY) evidence after approval, according to the authors, that shows the equivalence in efficacy and safety of biosimilars as used in practice. Governments and other payers also should encourage pharmacovigilance and other outcomes studies that produce the PSY data that will encourage interchangeability and greater price competition. Over time, biosimilar markets can become biogeneric, but governments and other payers need to behave differently to encourage this and realise savings. For example, price cuts after patent expiry and/or the use of reference pricing will deter biosimilar entry and reduce long term savings. Outcomes data also are important in helping assess the value for money of second generation biopharmaceutical products as compared to the first generation.

Keywords: The; Market; for; Biosimilars:; Evolution; and; Policy; Options (search for similar items in EconPapers)
JEL-codes: I1 (search for similar items in EconPapers)
Date: 2008-11-01
References: Add references at CitEc
Citations: View citations in EconPapers (9)

Downloads: (external link)
https://www.ohe.org/publications/market-biosimilar ... ket-for-biosimilars/ (application/pdf)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:ohe:briefg:000238

Access Statistics for this paper

More papers in Briefing from Office of Health Economics Contact information at EDIRC.
Bibliographic data for series maintained by Publications Manager ( this e-mail address is bad, please contact ).