Article Text

Download PDFPDF

Production costs and potential prices for biosimilars of human insulin and insulin analogues
  1. Dzintars Gotham1,
  2. Melissa J Barber2,
  3. Andrew Hill3
  1. 1 Faculty of Medicine, Imperial College London, London, UK
  2. 2 Harvard TH Chan School of Public Health, Harvard University, Boston, Massachusetts, USA
  3. 3 Department of Translational Medicine, Liverpool University, Liverpool, UK
  1. Correspondence to Dr Dzintars Gotham; dzintarsgotham{at}gmail.com

Abstract

Introduction High prices for insulin pose a barrier to treatment for people living with diabetes, with an estimated 50% of 100 million patients needing insulin lacking reliable access. As insulin analogues replace regular human insulin (RHI) globally, their relative prices will become increasingly important. Three originator companies control 96% of the global insulin market, and few biosimilar insulins are available. We estimated the price reductions that could be achieved if numerous biosimilar manufacturers entered the insulin market.

Methods Data on the price of active pharmaceutical ingredient (API) exported from India were retrieved from an online customs database. Manufacturers of insulins were contacted for price quotes. Where market API prices could not be identified, prices were estimated based on comparison of similarity, in terms of manufacturing process, with APIs for which prices were available. Potential biosimilar prices were estimated by adding costs of excipients, formulation, transport, development and regulatory costs, and a profit margin.

Results The manufacturing processes for RHI and insulin analogues are similar. API prices were US$24 750/kg for RHI, US$68 757/kg for insulin glargine and an estimated US$100 000/kg for other analogues. Estimated biosimilar prices were US$48–71 per patient per year for RHI, US$49–72 for neutral protamine Hagedorn (NPH) insulin and US$78–133 for analogues (except detemir: US$283–365).

Conclusion Treatment with biosimilar RHI and insulin NPH could cost ≤US$72 per year and with insulin analogues ≤US$133 per year. Estimated biosimilar prices were markedly lower than the current prices for insulin analogues. Widespread availability at estimated prices may allow substantial savings globally.

  • insulin
  • analogues
  • biosimilars
  • generics
  • universal health coverage
  • access
  • affordability
  • cost of production

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0

View Full Text

Statistics from Altmetric.com

Footnotes

  • Handling editor Nicola Foster

  • Contributors DG designed the study. DG and MJB collected and analysed the data and drafted the manuscript. AH provided critique of the manuscript.

  • Funding This analysis was funded by the ACCISS study, which is funded by The Leona M and Harry B Helmsley Charitable Trust and Stichting ICF.

  • Disclaimer The funder was not involved in the conduct of the study or the decision to submit. Representatives of the ACCISS study provided comments on the manuscript but did not make the final decision to submit for publication. The analysis in this paper is that of the authors alone and does not necessarily reflect the views of the Helmsley Charitable Trust or Stichting ICF. All references and conclusions are intended for educational and informative purposes and do not constitute an endorsement or recommendation from the Helmsley Charitable Trust or Stichting ICF.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Further data may be obtained from the corresponding author.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.