Health Aff (Millwood). 2013 Oct;32(10):1803-10. doi: 10.1377/hlthaff.2009.0196.
Biologics are medicines derived from a biological source. Their high prices and rapid uptake have raised hopes that with the gradual expiration of patents on the first generations of biologics, the advent of lower-cost follow-on products known as biosimilars will help "bend the cost curve." Although biosimilars have been available since 2006 within the European Union and are expected to save $15-$44 billion by 2020, the Food and Drug Administration (FDA) has yet to finalize the necessary regulatory processes for their approval in the United States. The European experience suggests, however, that once these are in place, the US biosimilar market may well emerge as bimodal: Initially, modestly discounted biosimilars deemed noninterchangeable with the original products will compete to become the initial treatment of choice in new patients. Subsequently, a second market may be anticipated for those products able to meet the FDA's higher standard for "interchangeability." In that market, discounts may be more dramatic.
生物制剂是从生物来源中提取的药物。由于其价格高昂，且应用迅速，人们希望随着第一代生物制剂专利的逐步到期，后续的低成本仿制药（称为生物类似药）的出现将有助于“降低成本曲线”。尽管自 2006 年以来，生物类似药已在欧盟上市，预计到 2020 年将节省 150 亿至 440 亿美元，但食品和药物管理局（FDA）尚未最终确定其在美国获得批准所需的监管程序。然而，欧洲的经验表明，一旦这些程序到位，美国的生物类似药市场很可能呈现双峰模式：最初，被认为与原产品不可互换的适度折扣的生物类似药将竞相成为新患者的初始治疗选择。随后，预计将为那些能够达到 FDA 更高的“可互换性”标准的产品开辟第二个市场。在这个市场中，折扣可能更为显著。
