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Production costs and potential prices for biosimilars of human insulin and insulin analogues

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...

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Autores principales: Gotham, Dzintars, Barber, Melissa J, Hill, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157569/
https://www.ncbi.nlm.nih.gov/pubmed/30271626
http://dx.doi.org/10.1136/bmjgh-2018-000850
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author Gotham, Dzintars
Barber, Melissa J
Hill, Andrew
author_facet Gotham, Dzintars
Barber, Melissa J
Hill, Andrew
author_sort Gotham, Dzintars
collection PubMed
description 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.
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spelling pubmed-61575692018-09-28 Production costs and potential prices for biosimilars of human insulin and insulin analogues Gotham, Dzintars Barber, Melissa J Hill, Andrew BMJ Glob Health Research 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. BMJ Publishing Group 2018-09-25 /pmc/articles/PMC6157569/ /pubmed/30271626 http://dx.doi.org/10.1136/bmjgh-2018-000850 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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
spellingShingle Research
Gotham, Dzintars
Barber, Melissa J
Hill, Andrew
Production costs and potential prices for biosimilars of human insulin and insulin analogues
title Production costs and potential prices for biosimilars of human insulin and insulin analogues
title_full Production costs and potential prices for biosimilars of human insulin and insulin analogues
title_fullStr Production costs and potential prices for biosimilars of human insulin and insulin analogues
title_full_unstemmed Production costs and potential prices for biosimilars of human insulin and insulin analogues
title_short Production costs and potential prices for biosimilars of human insulin and insulin analogues
title_sort production costs and potential prices for biosimilars of human insulin and insulin analogues
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157569/
https://www.ncbi.nlm.nih.gov/pubmed/30271626
http://dx.doi.org/10.1136/bmjgh-2018-000850
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