一项繁文缛节正使关键药物的价格居高不下。这些药物用于治疗自身免疫性疾病、糖尿病、癌症及其他某些慢性病。国会目前可以轻松完成的一件事，就是削减繁文缛节，改善患者获取满足其需求的低成本治疗的途径。争议的焦点在于一类被称为生物制剂的药物，这类药物通常源自生物体而非化学合成。由于其复杂性，生物制剂的制造、给药和储存更加耗费资源。
One piece of red tape is keeping the prices of critical medications too high. These medicines treat autoimmune diseases, diabetes, cancer, and certain other chronic conditions. One easy thing Congress could accomplish now is to cut away the red tape and improve access to lower-cost treatments that meet patients’ needs. The controversy concerns a type of drug known as biologics, which are typically produced from living organisms rather than synthesized chemicals. Because of their complexity, biologics are more resource-intensive to manufacture, administer and store.
然而，正是这种复杂性使它们能够治疗非生物制剂无法应对的疾病和紊乱。例如，胰岛素就是一种生物制剂药物。它让无法自行产生胰岛素的糖尿病患者得以调节血糖水平。目前尚无已知的化学药物能替代胰岛素。
However, their complexity also allows them to treat illnesses and disorders beyond what non-biologic treatments can. Insulin, for example, is a biologic medicine. It allows diabetic patients who can’t produce insulin to regulate their glucose levels. There is no known chemical-drug substitute for insulin.
这项繁文缛节源于2010年，当时国会通过了《生物制剂价格竞争与创新法案》。该法为生物制剂的仿制药版本——即生物类似药——创设了一条监管审批路径。该法案设立的流程使生物类似药在官僚层面上难以发挥其潜力。与仿制药一样，当一种生物制剂治疗药物的专利到期时，药厂便可开始生产与原研药竞争的生物类似药版本。
The red tape was imposed back in 2010 when Congress passed the Biologics Price Competition and Innovation Act. The law created a regulatory approval pathway for the generic drug version of biologics, called biosimilars. The process the act created makes it bureaucratically difficult for biosimilars to fulfill their potential. Like with generic drugs, when a patent expires for a biologic treatment, drug manufacturers can start producing the biosimilar versions that compete with the original product.
这种竞争会压低价格。曾经售价数千美元的药物，一旦有仿制药上市，便可用几美分购得。药物创新、生产，继而迎来仿制药竞争的这一过程，使挽救生命和延长生命的药物价格大幅下降。药价下降幅度之大，甚至让亚马逊等公司能够推出每月仅需几美元的处方药订阅服务。
This competition brings the price down. Drugs that were once thousands of dollars can be purchased for pennies once generic versions became available. This process of drug innovation, production, and then generic competition has caused the price of life-saving and life-extending drugs to drop precipitously. Drug prices have come down so much that companies like Amazon can offer a prescription drug subscription for dollars a month.
但当国会设立生物类似药审批流程时，并没有像仿制药那样只设立单一类别，2010年法律反而增设了一个更严格的标准——可互换性。虽然制造商必须证明其生物类似药与生物制品“高度相似”才能获批，但要满足更高的“可互换性”标准，还须提交额外证据，证明换药不会产生不同结果。设立这一不同标准导致各州和从业者依赖它。
But when Congress created the biosimilar process, instead of just creating a single category like generics have, the 2010 law imposed an additional, more difficult standard – interchangeability. While manufacturers must prove their biosimilar version is "highly similar" to the biologic product for approval, they must submit additional evidence that demonstrates that switching drugs does not produce different results to meet the higher “interchangeability” standard. Creating that different standard caused states and practitioners to rely on it.
许多州要求达到更高标准，药剂师才能用生物类似药替代处方上的品牌药。但如果取消额外要求，患者就能以极低成本获得几乎完全相同的药物，通过降低保费和自付额为患者和纳税人省钱。这一额外要求之所以成为障碍，部分原因是制造商认为这一额外步骤成本过高，不愿追求。结果是，监管机构认定为可互换的生物类似药太少。
Many states require the higher standard before pharmacists are able to substitute the biosimilar version for the prescribed brand-name version. But if the additional requirements were removed, patients could obtain practically identical drugs for a fraction of the cost, saving patients and taxpayers money through lower premiums and co-pays. Part of the reason this additional requirement has become a barrier is that manufacturers find this extra step too costly to pursue. As a consequence, too few biosimilars are deemed interchangeable by regulators.
解决办法是取消可互换性作为单独分类。我们不再需要那个单独标准。最初设立可互换性标准是为了给患者增加一层保护。立法者认为仅凭生物类似性不足以确保安全、有效和相似效果，因此要求药企先行证明。然而，过去15年已清楚表明，更高标准是“寻找问题的解决方案”。没有任何案例显示可互换性是必要的，其他国家也不对药品施加这一额外标准。
The solution is to remove interchangeability as a separate classification. We don’t need that separate standard anymore. Originally, the interchangeability standard was put in place as an extra layer of protection for patients. Legislators thought that biosimilarity wasn't enough to ensure safety, efficacy, and similar effects, so they required drugmakers to prove it first. However, over the past 15 years, it has become clear that the higher standard is a solution in search of a problem. There are no cases where interchangeability was shown to be necessary, and other countries do not impose this additional standard on drugs.
甚至连FDA也得出结论，认为这一额外标准没有必要。2024年，FDA提议放宽证明可互换性的要求。
Further, even the FDA has concluded that this additional standard is unnecessary. In 2024, it proposed relaxing the requirements for proving interchangeability.
FDA 发出信号，将允许制造商提供复杂的分析和测试，以证明新版本在结构上相似且表现一致，而非要求进行冗长且昂贵的研究，在该类研究中制造商需让患者在两种药物之间来回切换。FDA 对以往的转换分析进行了系统性回顾，发现死亡率或严重不良反应方面不存在差异。这意味着增加的要求全是成本、无任何收益。
Instead of lengthy and costly studies where the manufacturer would switch patients back and forth between the two drugs, the FDA signaled it would allow manufacturers to provide sophisticated analysis and tests that show the new version was structurally similar and would behave the same. The FDA conducted a systematic review of past switching analyses and found no differences in mortality or serious adverse effects. That means the increased requirements are all cost and no benefit.
但 FDA 新的宽松标准还不够。国会必须通过立法解决这一问题，以免未来政府恢复更严格的要求。此外，立法修正还将免除制造商遵守一个毫无意义的法律标准，该标准要求投入额外的时间和资源。《生物类似药消除繁文缛节法案》获得两党支持，已由参议院卫生、教育、劳工和养老金委员会一致通过。众议员奥古斯特·普夫格（共和党-得克萨斯州）和格雷格·兰兹曼（民主党-俄亥俄州）已在众议院提出该法案。
But the FDA's new relaxed standards are not enough. Congress must fix the problem with legislation so future administrations can’t revert to stricter requirements. Also, a legislative fix would relieve manufacturers of a pointless legal standard that requires additional time and resources. The Biosimilar Red Tape Elimination Act has bipartisan support and was already approved unanimously by the Senate Health, Education, Labor and Pensions Committee. It's been introduced in the House by Reps. August Pfluger (R-Texas) and Greg Landsman (D-Ohio).
国会可在大选后完成立法。时间紧迫。专家估计，2025 年至 2034 年间将有 118 种生物制剂失去专利保护，生物类似药的竞争可为美国医疗体系节省 1890 亿美元。国会行动越快，就能越快激发竞争，为美国民众降低药价。杰里米·尼戈西安是位于华盛顿特区的自由市场公共政策组织——竞争企业研究所的高级研究员兼经济学家。
Congress could finish the job after the election. The clock is ticking. Between 2025 and 2034, experts estimated that 118 biologics will lose patent protection, and competition from biosimilar products could save the U.S. health care system $189 billion. The faster Congress acts, the faster they will spark competition and bring drug prices down for Americans. Jeremy Nighohossian is a senior fellow and economist with the Competitive Enterprise Institute, a free market public policy organization based in Washington, D.C.