The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond
Journal
Journal of Food and Drug Analysis
Journal Volume
27
Journal Issue
3
Pages
671-678
Date Issued
2019
Author(s)
Abstract
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. ? 2019
Subjects
Biosimilar; United States of America
Other Subjects
biological product; biosimilar agent; filgrastim; generic drug; drug industry; drug information; drug labeling; drug marketing; drug safety; drug storage; health care policy; human; immunogenicity; patent; pharmacovigilance; Review; United States
Type
review