首页 | 本学科首页   官方微博 | 高级检索  
检索        


The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond
Authors:Lin-Chau Chang
Institution:School of Pharmacy, College of Medicine, National Taiwan University, 33 Linsen S. Rd., Zhongzheng Dist., Taipei City, 10050, Taiwan
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.
Keywords:Fax: +886 02 23919098    Biosimilar  United States of America
本文献已被 ScienceDirect 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号