Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autor principal: Chang, Lin-Chau
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taiwan Food and Drug Administration 2019
Materias:
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
_version_ 1784752678676463616
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
work_keys_str_mv AT changlinchau thebiosimilarpathwayintheusaananalysisoftheinnovatorcompanyandbiosimilarcompanyperspectivesandbeyond
AT changlinchau biosimilarpathwayintheusaananalysisoftheinnovatorcompanyandbiosimilarcompanyperspectivesandbeyond