Zhai Mike Z, Sarpatwari Ameet, Kesselheim Aaron S
An instructor in medicine at Harvard Medical School in Boston, Massachusetts, and the assistant director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital.
A professor of medicine at Harvard Medical School in Boston, Massachusetts, and the director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital.
AMA J Ethics. 2019 Aug 1;21(8):E668-678. doi: 10.1001/amajethics.2019.668.
Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access. However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to patients, overall utilization has been limited. This article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.
生物制剂是美国最昂贵的处方药之一，给患者获得必要治疗带来了重大障碍。生物仿制药是由不同制造商生产的与生物制剂近乎相同的版本，2010年国会设立了简化审批途径，以刺激竞争，希望降低成本并扩大可及性。然而，截至2019年2月，仅17种生物仿制药获得批准，目前仅有7种上市。在目前患者可获得的少数生物仿制药中，总体使用情况有限。本文考察了生物仿制药市场的现状，描述了生物制剂制造商为延缓市场进入和阻止生物仿制药处方而采用的策略，并评估了与增加生物仿制药采用率相关的伦理问题。
