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The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond
In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Taiwan Food and Drug Administration
2019
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307033/ https://www.ncbi.nlm.nih.gov/pubmed/31324283 http://dx.doi.org/10.1016/j.jfda.2019.03.003 |
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author | Chang, Lin-Chau |
author_facet | Chang, Lin-Chau |
author_sort | Chang, Lin-Chau |
collection | PubMed |
description | In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of the biosimilar pathway, influenced related companies by studying their respective perspectives and strategies revealed in literatures and publicly available resources. Perspectives of companies reveal the points of concern for the biosimilar pathway, such as data requirements, patents, interchangeability, naming, and exclusivity. Innovator companies may utilize expedited programs for serious conditions, enhance patent protection, launch programs for life-cycle extension, and develop biosimilars as well. The biosimilar companies overcoming technical barriers might need to gather convincing evidence to facilitate market penetration as well as to distinguish their products from those of other biosimilar competitors. More challenges are expected for innovator companies if international harmonization takes place, which might be worth further investigation. |
format | Online Article Text |
id | pubmed-9307033 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Taiwan Food and Drug Administration |
record_format | MEDLINE/PubMed |
spelling | pubmed-93070332022-08-09 The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond Chang, Lin-Chau J Food Drug Anal Review Article In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of the biosimilar pathway, influenced related companies by studying their respective perspectives and strategies revealed in literatures and publicly available resources. Perspectives of companies reveal the points of concern for the biosimilar pathway, such as data requirements, patents, interchangeability, naming, and exclusivity. Innovator companies may utilize expedited programs for serious conditions, enhance patent protection, launch programs for life-cycle extension, and develop biosimilars as well. The biosimilar companies overcoming technical barriers might need to gather convincing evidence to facilitate market penetration as well as to distinguish their products from those of other biosimilar competitors. More challenges are expected for innovator companies if international harmonization takes place, which might be worth further investigation. Taiwan Food and Drug Administration 2019-04-30 /pmc/articles/PMC9307033/ /pubmed/31324283 http://dx.doi.org/10.1016/j.jfda.2019.03.003 Text en © 2019 Taiwan Food and Drug Administration https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ). |
spellingShingle | Review Article Chang, Lin-Chau The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title | The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title_full | The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title_fullStr | The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title_full_unstemmed | The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title_short | The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond |
title_sort | biosimilar pathway in the usa: an analysis of the innovator company and biosimilar company perspectives and beyond |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307033/ https://www.ncbi.nlm.nih.gov/pubmed/31324283 http://dx.doi.org/10.1016/j.jfda.2019.03.003 |
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