School of Pharmacy, College of Medicine, National Taiwan University, 33 Linsen S. Rd., Zhongzheng Dist., Taipei City, 10050, Taiwan.
J Food Drug Anal. 2019 Jul;27(3):671-678. doi: 10.1016/j.jfda.2019.03.003. Epub 2019 Apr 30.
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.
为了改善昂贵的生物治疗药物的可及性，美国于 2009 年根据《生物制品价格竞争与创新法案》（BPCI 法案）建立了生物类似药途径。本研究旨在通过研究文献和公开资源中揭示的各自观点和策略，调查该卫生政策（即生物类似药途径的建立）是如何影响相关公司的。公司的观点揭示了对生物类似药途径的关注点，例如数据要求、专利、可互换性、命名和专有权。创新型公司可能会利用严重疾病的加速程序、加强专利保护、推出生命周期延长计划以及开发生物类似药。克服技术障碍的生物类似药公司可能需要收集有说服力的证据，以促进市场渗透，并将其产品与其他生物类似药竞争对手区分开来。如果国际协调统一，如果发生这种情况，创新型公司可能会面临更多挑战，这值得进一步调查。
