Rituximab biosimilar (mAbxience)

复旦大学新时代研究生医学英语综合教程 课本Unit 1,2,3,4,5,6,7 text A课后单词、课堂练习单词及写作知识Unit 3 Drug Development and Clinical Trials 药物研发与临床试验（一）Text 1 Breaking Down Barriers: Why Biosimilars Face Resistance in the US Market打破壁垒：为何生物类似药在美国市场面临阻力（1）文章总结： 这篇文章以美国市场为例，系统性地探讨了生物类似药在发展中面临的机遇、挑战与未来前景。以下是核心内容的梳理： 一、机遇与优势：为何要发展生物类似药？ 1.降低成本，提高可及性：生物类似药平均价格比原研药低约50%，能为医保系统节省巨额开支（文中举例，生物药占美国医保处方量的2%，却占其药物支出的40%），并将节省的资金用于其他创新治疗。患者自付费用也能大幅降低。 2.引入竞争，优化市场：通过“上市前竞争”打破原研药的垄断，迫使整个药品定价体系更趋合理，是控制医疗成本上涨的关键。 3.安全有效，标准严格：FDA对生物类似药的审批是“黄金标准”，要求其与原研药在安全性、有效性上“无临床意义的差异”，并需经过严格测试和上市后监测。 二、挑战与阻力：为何在美国市场普及缓慢？ 尽管优势明显，但生物类似药在美国的采用速度远低于预期，主要阻力来自： 1.系统性与市场准入障碍： o药品福利管理机构的限制：PBM通过处方集、报销政策等限制生物类似药的可及性，实质上代替医生和患者做出了临床与经济选择，阻碍了价格竞争。 o“可互换”认定的困惑与争议：该制度本意为简化药剂师替换流程，但被误解为质量分级。FDA已建议删除此认定，强调所有获批的生物类似药都同等安全有效。 2.认知与信心问题： o医护人员与患者疑虑：对转换药物存在安全性担忧（尽管全球数据支持安全）、对新给药装置不熟悉、对品牌变更感到不安。 o“反安慰剂效应”：因信息不足或负面预期，导致患者主观感觉更差或停药。 o教育与支持不足：患者和医生均反映，在强制转换政策中，来自支持组织、药企和政府的培训、信息及支持严重不足。 3.国际经验中的普遍问题：即便在生物类似药应用更早的欧洲和新西兰，强制转换政策也暴露出医患沟通不畅、决策参与度低、后勤支持（如设备培训、耗材变更）混乱等问题，导致满意度下降和医护人员工作量增加。 三、未来展望与解决方案 1.政策与监管改革：美国国会已开始审视现有政策，旨在优化处方集、保险角色和医疗服务提供机制，确保生物类似药的成本节约潜力得以实现。 2.多方协作是关键：需要监管机构、保险公司、药品福利管理机构、药企、医生、患者共同推动。核心是促使药品福利管理机构从依赖“回扣”转向支持“价格竞争”。 3.加强教育与沟通：这是破除疑虑的基石。需向医患双方透明地传达生物类似药的科学严谨性、审批标准、经济益处，并在药物转换时提供充分的设备培训、信息支持和持续护理。 4.长期前景依然乐观：随着经验积累，监管流程将更顺畅，医疗系统效率将提升，医生信心会增强。生物类似药市场有望持续扩张，最终让更多患者更早、更便宜地获得能改变生活的治疗，减轻慢性病负担。 核心结论 本文揭示了生物类似药推广是一个复杂的系统性问题，而非简单的科学或价格问题。其成功不仅取决于药物本身的科学严谨性与价格优势，更有赖于打破既有的市场利益结构、弥补关键参与者的认知差距，并通过有效的政策和教育构建一个支持竞争、以患者为中心的医疗生态系统。（2）正文 1、Through the recent introduction of 9 US Food and Drug Administration (FDA)-approved adalimumab (Humira) biosimilars, with more in the pipeline, the US is experiencing a biosimilar boom. These drugs represent an opportunity to deliver more treatment options at a potential discount compared with reference biologics. 随着近期9款美国食品药品监督管理局批准的阿达木单抗（商品名：修美乐）生物类似药的上市，以及更多类似药正处于研发阶段，美国正经历一场生物类似药的热潮。与参照生物制剂相比，这些药物为患者提供了更多治疗选择，并且价格可能更低。 in the pipeline 核心含义：“在进行中”、“在筹备中”、“在研发/审批流程中” 2、On average, biosimilars cost about 50% less than the reference brand. This reduction in costs can benefit both the healthcare system and patients, especially those whose out-of-pocket payments are based on a drug’s list price. 平均而言，生物类似药的成本比原研品牌低约50%。这种成本降低可以使医疗系统和患者都受益，特别是对于那些自付费用基于药品定价的患者而言。 3、Biosimilars also play a critical role in healthcare by introducing pre-market competition. Juliana Reed, MS, executive director of the Biosimilars Forum, explained to HCPLive that this is particularly significant when considering biologic medications, without competition, account for 40% of Medicare’s drug costs despite only constituting 2% of its prescriptions. 生物类似药在医疗保健领域还发挥着至关重要的作用，即引入上市前竞争。生物类似药论坛的执行主任朱莉安娜·里德向HCPLive解释说，考虑到生物制剂在没有任何竞争的情况下，其处方量仅占2%，但花费却占到了医保药物费用的40%，这种竞争意义尤为重大。 4、“Now that biosimilars are coming to the market, we should be able to see that 40% of Medicare’s cost with competition go down,” she said. “And when those costs go down, Medicare will have more money to spend on other medicines, new innovations, and new treatments for Medicare beneficiaries.” “既然生物类似药正在进入市场，我们应该能预期，随着竞争加剧，医保支出中这部分原本占40%的费用将会下降。”她说，“而当这部分成本下降时，医保将有更多资金用于为参保人购买其他药物、支持创新以及提供新的治疗方案。” 5、Increased competition from biosimilars in the market can also potentially decrease overall healthcare system costs, redirecting resources to other healthcare areas. 市场中的生物类似药带来的竞争加剧，还可能降低整个医疗系统的总成本，从而将资源重新分配到其他医疗领域。 6、Despite this influx, the adoption of biosimilars in the US has been unexpectedly slow. Factors including interchangeability designation, pharmacy benefit managers (PBMs) limiting access to the drugs, and a lack of knowledge and comfortability with biosimilars among providers and patients have made it difficult for biosimilars to flourish in the US market the way they have in many other parts of the world. A.然而，尽管生物类似药大量涌现，其在美国市场的普及速度却出人意料地缓慢。包括“可互换”认定、药品福利管理机构的准入限制，以及医疗从业者和患者对生物类似药认知不足、接受度不高等因素，都阻碍了生物类似药像在世界许多其他地区那样在美国市场蓬勃发展。 B.尽管生物类似药大量涌入,但美国对其的采纳速度却出乎意料地缓慢。影响因素包括可互换性认定、药品福利管理公司(PBM)限制药物获取,以及医疗服务提供者和患者对生物类似药缺乏了解和接纳度。这些因素使得生物类似药难以像在世界其他许多地区那样在美国市场蓬勃发展。 Influx涌入 Addressing Safety and Efficacy Concerns解决安全性与有效性担忧 7、Prior to FDA approval, biosimilars must meet strict criteria, ensuring no clinically meaningful differences in safety and efficacy compared with the reference product. These drugs undergo extensive testing, and post-approval monitoring ensures continued safety and effectiveness. 在获得FDA批准之前，生物类似药必须满足严格标准，确保在安全性和有效性方面与参照产品相比不存在具有临床意义的差异。这些药物需经过大量测试，且上市后监测可确保持续的安全性和有效性。 8、However, clinicians and patients regularly express hesitancy when making the decision to initiate treatment with a biosimilar 然而，临床医生和患者在选择开始使用生物类似药进行治疗时，常常表现出犹豫。Initiate启动 9、To combat this, Russell D Cohen, MD, gastroenterologist and professor at University of Chicago Medicine, stressed the importance of education to increase the understanding among providers and patients of the scientific rigor behind the development of biosimilars, as well as the benefits of these drugs. 为应对这一问题，芝加哥大学医学院的胃肠病学家、医学博士拉塞尔·D·科恩强调了教育的重要性，以增进医疗提供者和患者对生物类似药开发背后科学严谨性的理解，并认识这些药物的益处。rigor严格 10、“With my patients, I explain that the potential side effects associated with biosimilars are similar to those associated with the reference biologic, so, generally, patients should not experience any change in dosage or treatment plan,” he said. “I also assure patients that the FDA carefully reviews studies of biosimilars to ensure there are no clinically meaningful differences in safety or effectiveness compared to the original biologic.” “面对我的患者，我会解释，生物类似药可能产生的副作用与参照生物制剂相似，因此通常患者不会在剂量或治疗方案上感受到任何变化，”他说，“我还向患者保证，FDA会仔细审查生物类似药的研究，以确保其在安全性或有效性方面与原始生物制剂相比不存在具有临床意义的差异。” 11、He also stressed healthcare providers should consider the possible financial burden on patients when prescribing treatment. With an influx of lower-priced biosimilar options available, cost can now be a part of the discussion of care. The introduction of more biosimilars also has the potential, through a redirection of funds, to enhance patient experiences through innovation, such as advancements in usability and pain reduction associated with injection devices. Educating patients about these direct and indirect advantages can aid in informed decision-making. 他还强调，医疗提供者在开具处方时应考虑患者可能面临的经济负担。随着大量价格更低的生物类似药进入市场，费用现在可以成为治疗讨论的一部分。更多生物类似药的引入，还可能通过资金的重新配置，在易用性、减轻注射疼痛等方面提升患者体验，这些创新能够改善患者体验。对患者进行这些直接和间接益处的教育，有助于他们做出知情决策。 12、“FDA approval is the gold standard around the world,” Reed emphasized. “The FDA will not approve a biosimilar unless it is seen as safe and efficacious with the same clinical results in quality as its reference product.” “FDA的批准是世界范围内的黄金标准，”里德强调，“除非一种生物类似药被认定是安全有效的，并且在质量上与参照产品具有相同的临床结果，否则FDA不会批准它。” Challenges and Barriers to Access 挑战与获取障碍 13、Challenges exist in accessing biosimilars within the US healthcare system and providers often follow insurance preferences due to system complexities. Additional barriers arise from formulary restrictions and insurance coverage, making it challenging for HCPs to prescribe specific biosimilars. 在美国医疗体系内，获取生物类似药面临诸多挑战，由于体系复杂，医疗服务提供者通常需遵循保险公司的偏好。额外的障碍来自于规定的限制和保险覆盖范围，这使得医疗专业人员开具特定生物类似药处方变得困难。 Interchangeability可互换性 14 In the US, interchangeability allows pharmacists to substitute biosimilars for the originator without prescriber permission. An interchangeable designation requires additional switching studies, ensuring the same clinical outcomes upon interchange and was initially designed to simplify access and accelerate medication availability. 在美国，"可互换"许可允许药剂师在未经处方医生同意的情况下，用生物类似药替代原研药。获得"可互换"认定需要额外的转换研究，以确保互换后产生相同的临床结果。该制度最初旨在简化药物获取并加快药品供应。 15 However, this designation has been under scrutiny, as demonstrated by the recent FDA draft guidance recommending removing it from the product’s prescribing information. 然而，这一认定正受到审查，近期FDA发布的指导草案建议将其从产品处方信息中删除，正体现了这一点。demonstrate证明 16“Part of the reason for that new recommendation is that we know an interchangeability designation does not mean one biosimilar is better or more biosimilar than another,”Jessica Oman, PharmD, vice president of Medical Affairs for the US biopharmaceuticals team at Fresenius Kabi told HCPLive. “That’s all proven through pharmacokinetics, analytical assessments, and clinical trials. It basically just means a particular company chose to do an additional study that required multiple switches between that particular biosimilar as well as the reference product.” 费森尤斯卡比美国生物制药团队医学事务副总裁、药学博士杰西卡·奥曼向HCPLive解释道："该新建议的部分原因在于，我们知道'可互换'认定并不意味着某一生物类似药优于其他类似药，或'更具生物相似性'。这已通过药代动力学、分析评估和临床试验得到充分证实。它基本上只意味着特定公司选择进行了一项额外研究，该研究要求在该特定生物类似药与参照产品之间进行多次转换。" 17 Understanding this definition is crucial as the biggest concern expressed by providers is the safety of switching between a biologic and biosimilar, although data and experiences globally support the safety of switching without negative outcomes. Additional issues surrounding branding differences and misconceptions about quality necessitate robust education and support. 理解这一定义至关重要，因为医疗提供者最大的担忧是在生物制剂和生物类似药之间切换的安全性，尽管全球的数据和经验支持安全转换且不会产生负面结果。围绕品牌差异和对质量的误解的其他问题需要强有力的教育和支持。misconception误解 18“A lack of education and exposure can heighten the nocebo response,”Gasteiger noted. “Confidence from healthcare providers, transparent education, and the continuity of patient support will be critical in these moments.” 加斯泰格指出：“缺乏教育和接触会加剧反安慰剂的反应。”“在这些时刻，医疗保健提供者的信心、透明的教育和对患者的持续支持至关重要。” 19、Another concerning aspect is the limited market access to biosimilars due to blockades from PBMs. This obstruction prevents cost-saving competition and inhibits patients from accessing lower-cost medicines, causing financial hardship. Such limitations might discourage future investment in biosimilar development, raising questions about the sustainability of the biosimilars market long-term. 另一个令人担忧的方面是由于药品监督管理机构的封锁，生物仿制药的市场准入有限。这种障碍阻碍了节约成本的竞争，并阻碍患者获得成本较低的药物，造成经济困难。这些限制可能会阻碍未来对生物仿制药开发的投资，从而对生物仿制药市场的长期可持续性提出质疑。 20、“PBMs are making clinical decisions about the access to medicines and to lower cost medicines that should be between the patient and the physician,” Reed explained. “Adalimumab is a very expensive medicine and patients, if they had access to the adalimumab biosimilars, could be saving 85%. That’s how big the discounts are.”  Reed解释说：“药品福利管理机构正在做出关于获得药物和降低药物成本的临床决定，这应该在病人和医生之间进行。”“阿达木单抗是一种非常昂贵的药物，如果患者能够获得阿达木单抗生物仿制药，他们可以节省85%的费用。折扣就是这么大。” 21 The emphasis remains on pressing PBMs to prioritize lowering costs through competition rather than relying solely on rebates. Collaboration among stakeholders is essential for realizing the potential benefits of biosimilars in the healthcare landscape.  重点仍然是敦促药品福利管理机构优先考虑通过竞争而不是仅仅依靠回扣来降低成本。利益相关者之间的合作对于实现生物仿制药在医疗保健领域的潜在利益至关重要。 The Clinician and Patient Perspective临床医生和病人的观点 22、Although the adoption of biosimilars has been slower than anticipated in the US, they have long been established internationally. Despite this familiarity, prescriber confidence and knowledge gaps are still present outside the US, leading to uncertainty and misinformation. Brand changes can disrupt patient care, which can lead to discontinuation and nocebo effects.  A.尽管生物仿制药的采用在美国比预期的要慢，但它们在国际上早已确立。尽管有这种熟悉，但在美国以外，处方者的信心和知识差距仍然存在，导致不确定性和错误信息。品牌变化可能会扰乱患者护理，从而导致停药和反安慰剂效应。 B.尽管生物类似药在美国的应用比预期缓慢，但国际上早已广泛使用。即便如此，在美国以外的地区，处方医师的信心和认知差距依然存在，导致了不确定性和错误信息的产生。品牌变更可能干扰患者的治疗连续性，进而导致治疗中断和反安慰剂效应。 23 Chiara Gasteiger, PhD, postdoctoral scholar in the Mind & Body Lab at Stanford University, and her team explored the experiences of 117 rheumatology patients and 164 healthcare providers regarding a mandated nationwide transition adalimumab biosimilar in New Zealand.  斯坦福大学身心实验室博士后学者Chiara Gasteiger博士和她的团队探讨了117名风湿病患者和164名医疗保健提供者在新西兰强制性过渡阿达木单抗生物类似药方面的经验。mandated强制规定的”、“法律要求的”或“命令的”。 mandated nationwide transition全国性强制转换政策 24 “Patients reported low satisfaction with the support and information they received from patient support organizations, a lack of training for the device, and issues with the changes in care supplies and patient support program,” Gasteiger told HCPLive. “Similarly, providers (rheumatologists, rheumatology nurses and pharmacists) experienced an increased workload and were unsatisfied with the training for the biosimilar device and the information they received from government agencies.”  加斯泰格尔向HCPLive表示：“患者报告称，他们对从患者支持组织获得的支持和信息满意度较低，缺少对新给药装置的使用培训，并且在护理耗材和患者支持项目的变更方面遇到问题。同样，医疗服务提供者（风湿病医生、风湿科护士和药剂师）的工作量增加，并且对生物类似药给药装置的培训以及从政府机构获得的信息感到不满意。” 25 Gasteiger noted similar results from a cross-sectional study conducted in the UK, which examined the perceptions and experiences of patients switching from the biologic to an adalimumab biosimilar. Many patients were unsatisfied post-switch, underscoring the importance of communication, shared decision-making, training with the new device, and educational information to maximize treatment outcomes.  加斯泰格尔指出，英国一项横断面研究也显示了类似结果，该研究调查了患者从原研生物制剂转换为阿达木单抗生物类似药的看法和体验。许多患者在转换后感到不满意，这凸显了沟通、共同决策、新装置使用培训和教育信息对于实现最佳治疗效果的重要性。 26 Improving biosimilar acceptance requires an international collaborative approach and enhanced education. The Future of Biosimilars in the US  提高生物类似药的接受度需要国际协作和加强教育。 27 The introduction of the adalimumab biosimilars brought attention to the functioning of our healthcare system. Contrary to expectations, the adoption of adalimumab biosimilars in the US market has not been as rapid as anticipated.  阿达木单抗生物类似药的推出引起了人们对我们医疗体系运作方式的关注。与预期相反，阿达木单抗生物类似药在美国市场的采用并未如预期般迅速。functioning运作 28 This discrepancy has prompted Congress to scrutinize existing policies, with a growing interest in understanding why other countries have successfully transitioned to biosimilars, resulting in significant healthcare cost savings, while the US lags behind. This has prompted policymakers to reassess structures, including formularies, insurer roles, and healthcare delivery mechanisms, aiming to ensure the anticipated cost savings from biosimilars become a reality.  这种差异促使国会开始审视现有政策，并对了解为何其他国家能成功过渡到生物类似药（从而大幅节省医疗成本）而美国却落后，表现出越来越大的兴趣。这促使政策制定者重新评估包括处方集、保险机构作用和医疗服务提供机制在内的结构，旨在确保生物类似药预期的成本节约成为现实。 29 “If stakeholders, including the PBMs, support biosimilar uptake and demand patients have access to competition and lower costs, I think the biosimilars industry could be robust,” Reed said. 里德表示：“如果包括药品福利管理机构在内的所有利益相关方都支持生物类似药的采用，并要求患者能够获得竞争选择和更低成本，我认为生物类似药产业可以蓬勃发展。” 30、As healthcare systems gain experience, Gasteiger believes there will be increased confidence, streamlined regulatory processes, and improved administrative efficiency for healthcare providers, and the biosimilars market will continue to expand.  随着医疗体系经验的积累，加斯泰格尔相信，医疗服务提供者的信心将会增强，监管流程将更顺畅，行政效率将提高，生物类似药市场也将持续扩大。 31 “A lot of the conditions that these biosimilars treats can cause permanent life changing outcomes or irreversible damage,” Oman stated. “With biosimilars, the hope is that they can get these medications sooner and it is easier for the healthcare providers to have access to them as well.”  奥曼指出：“许多生物类似药治疗的疾病可能导致永久性的、改变生活的后果或不可逆的损伤。对于生物类似药，我们希望患者能更早获得这些药物，医疗服务提供者也能更容易地获取它们。” 32 Biosimilars offer a significant opportunity in healthcare by providing life-changing medications to patients in need. Ultimately, the goal is to make biosimilars more accessible to patients and healthcare providers, aligning with their potential to positively impact patients’ lives. Continued progress in this direction will allow patients to receive these treatments when needed, reducing the burden of chronic diseases, and improving their quality of life. 生物类似药为有需要的患者提供改变生活的药物，是医疗保健领域的一个重要机遇。最终目标是让患者和医疗服务提供者更容易获得生物类似药，这与其对患者生活产生积极影响的潜力相符。朝着这个方向持续取得进展，将确保患者在需要时能够获得这些治疗，减轻慢性疾病的负担，并改善他们的生活质量。 align“使一致、使对齐、使匹配”（3）单词 Food and Drug Administration: 美国食品药品监督管理局。 Medicare:联邦医疗保险 pharmacy benefit managers (PBMs): 药物福利管理者 healthcare professionals: 医务人员 nocebo effect: 反安慰剂效应 PPT加红单词 英文短语 中文翻译 核心解析（医药 / 医保场景） potential discount 潜在折扣 多指药品采购、医保谈判中可能达成的价格优惠幅度 reference biologics 参照生物制剂 / 原研生物药 生物类似药研发时作为对照基准的原研生物制品 access to 可及性；获得途径 常用搭配：access to medicines  药品可及性 rigor 严谨性；严格性 指研究设计、审评审批、质量控制的规范与严格程度 the gold standard 金标准 某领域公认最权威、最可靠的方法 / 标准 / 药物 dispensing 药品调配；发药 药师按处方核对、发放药品的行为，区别于开方 not prescribing 不开具处方；非处方行为 强调医师不进行处方开具，仅做诊断或建议 branding difference 品牌差异 不同厂家药品商品名、包装、品牌定位上的区别 misconceptions about quality 对质量的误解 患者 / 医护对仿制药、生物类似药质量安全性的错误认知 robust 稳健的；可靠的 形容研究证据、数据、质量体系充分且可信 mandated 法定的；强制要求的 由法规、政策强制性规定的行为或标准 perceptions 认知；看法 医护、患者、政策方对药品 / 医疗服务的主观认知 cross-sectional study 横断面研究 流行病学常用研究方法，某一时点人群现状调查 lags behind 落后于；滞后 指某国 / 地区在药品政策、可及性、技术上不及国际水平 formularies 处方集；药品目录 医院 / 医保机构收录可报销、可使用的药品清单 healthcare delivery mechanisms 医疗服务供给机制 医疗资源分配、诊疗服务提供、药品流通等运行体系（4）课后习题 1. Choose the best answer from A, B, C and D according to the passage.  ( 1 ) What is the primary obstacle to biosimilar adoption in the US?  A. Healthcare providers’ resistance due to safety concerns.  B. Systemic barriers created by market intermediaries.  C. Patients’ preference for reference biologics.  D. Limited and insufficient pathways approved by FDA.  ( 2 ) Which of the following can best describe interchangeability designation?  A. It ensures higher quality standards for biosimilars.  B. It has become a barrier rather than a facilitator for market access. C. It simplifies the prescription process for healthcare providers.  D. It increases patient confidence in biosimilar products.  ( 3 ) Which of the following can best describe interchangeability?  A. Interchangeability designation speeds up biosimilar’s market entry.  B. FDA adheres to interchangeability labelling due to safety and efficacy.  C. With further switching studies, pharmacists can substitute certain medications without prior approval.  D. Interchangeability worsens patients’ nocebo response. ( 4 ) What does the author imply by comparing international and US biosimilar markets? A. Cultural differences are the main factor in adoption rates.  B. Regulatory frameworks determine market success.  C. The mismatch between policy design and market interest is the key to the US lagging behind.  D. Proper education is sufficient to ensure successful adoption. ( 5 ) Which statement best reflects the author’s perspective on biosimilar education?  A. It should focus primarily on cost benefits to encourage adoption.  B. It requires a multi-stakeholder approach addressing various concerns.  C. Technical information about manufacturing is most important.  D. Patient education matters more than provider education. 翻译 1. 根据文章内容，从A、B、C、D四个选项中选择最佳答案。 （1）美国采用生物类似药的主要障碍是什么？ A.出于安全考虑，医疗服务提供者的抵制。 B.市场中介造成的系统性障碍。 C.患者对原研生物制剂的偏好。 D.美国食品药品监督管理局批准的有限且不足的途径。 （2）以下哪项最能描述“可互换性” designation（指定）？ A.它确保生物类似药有更高的质量标准。 B.它已成为市场准入的障碍而非推动因素。 C.它简化了医疗服务提供者的处方流程。 D.它增强了患者对生物类似药的信心。 （3）以下哪项最能描述“可互换性”？ A.可互换性指定加快了生物类似药的市场准入。 B.出于安全性和有效性考虑，美国食品药品监督管理局坚持采用可互换性标签。 C.经过进一步的转换研究，药剂师无需事先批准即可替代某些药物。 D.可互换性加剧了患者的反安慰剂效应。 （4）作者通过比较国际与美国生物类似药市场暗示了什么？ A.文化差异是采用率的主要影响因素。 B.监管框架决定了市场成功。 C.政策设计与市场利益不匹配是美国落后的关键。 D.适当的教育足以确保成功采用。 （5）哪项陈述最能反映作者对生物类似药教育的看法？ A.应主要关注成本效益以鼓励采用。 B.需要采取多方利益相关者方法来解决各种问题。 C.关于制造的技术信息最为重要。 D.患者教育比医疗服务提供者教育更重要。 这三道题的答案是：1. B，2. B，3. C。 根据你提供的文档内容，我为你整理了详细的解析，帮助你理解为什么选这些答案。 📝答案速查表 题号 1 2 3 4 5 答案 B B C C B 🔍详细解析 1. B (Systemic barriers created by market intermediaries)原句：      What is the primary obstacle to biosimilar adoption in the US?解析：文档Section: Challenges and Barriers to Access和Section:      Addressing Safety and Efficacy Concerns中提到：第6段指出，虽然医生和患者有犹豫（Hesitancy），但主要因素是"pharmacy benefit managers (PBMs) limiting access to the       drugs"（药房福利管理者限制药物获取）。第13段进一步说明，由于系统复杂性（System       complexities），提供者通常遵循保险偏好，且存在"formulary restrictions"（处方集限制）。这些都属于“市场中介（PBMs、保险公司）造成的系统性障碍”，因此B是最准确的描述。虽然A选项（医生的担忧）在文中也有提及，但文中的表述是"Factors including..."（包括...在内的因素），而PBMs和系统复杂性被强调为更核心的结构性障碍。 2. B (It has become a barrier rather than a facilitator for market access)原句：      Which of the following can best describe interchangeability designation?解析：文档Section: Interchangeability中提到：第14段说明，互换性（Interchangeability）最初的设计目的是"simplify access"（简化获取），即作为促进因素。然而，第15段指出"this designation has been under scrutiny"（该指定正受到审查），且第16段提到互换性指定并不意味着药物更好，只是意味着公司做了额外的研究。结合第1段中提到的“尽管有生物类似药，但美国采用率出人意料地缓慢”，以及第15段FDA甚至建议从说明书移除该标识的背景，说明这个designation在实际操作中并没有起到很好的促进作用，反而因为额外的研究要求或定义模糊成为了负担。因此，它现在更像是一种障碍（Barrier）而非促进因素（Facilitator）。 3. C (With further switching studies, pharmacists can substitute certain medications without prior approval)原句：      Which of the following can best describe interchangeability?解析：文档Section: Interchangeability第14段是定义互换性的关键句：原文："In       the US, interchangeability allows pharmacists to substitute biosimilars       for the originator without prescriber permission. An interchangeable       designation requires additional switching studies..."这句话明确指出了两个核心点：1.      需要额外的转换研究（Additional       switching studies）；2.      允许药剂师在无处方者许可的情况下进行替换（Substitute...       without prescriber permission）。选项C是对原文最精准的复述。选项A和D文中未提及，选项B虽然提到FDA和安全有效性，但文中第12段是关于FDA批准标准的讨论，而非专门定义“互换性”。 4. C (The mismatch between policy design and market interest is the key to the US lagging behind)原句： What      does the author imply by comparing international and US biosimilar      markets?解析： 文档 Section:      The Future of Biosimilars in the US 中的 Policy      Scrutiny and Reform 部分（第...段，文档中未标号但位于该章节下半部分）提到：原文："This       discrepancy has prompted Congress to scrutinize existing policies...       while the US lags behind."（这种差异促使国会审查现有政策……而美国却落后了。）文中指出，其他国家成功转型并节省了成本，而美国却滞后。这种对比暗示了美国的政策设计（如处方集、保险公司角色等）与市场对低成本药物的需求之间存在错位（Mismatch）。因此，选项 C 准确概括了作者通过对比想要表达的核心观点。 5. B (It requires a multi-stakeholder approach addressing various concerns)原句： Which      statement best reflects the author’s      perspective on biosimilar education?解析： 文档 Section:      The Future of Biosimilars in the US 中的 Improving      Biosimilar Acceptance 部分（文档第95页上方）明确提到：原文："Improving       biosimilar acceptance requires an international collaborative approach       and enhanced education."此外，在 Addressing       Safety and Efficacy Concerns 部分（第9段），专家强调教育需要针对 providers       and patients（医生和患者）。在 Stakeholder       Support for Biosimilars 部分（第...段），文中提到包括 PBMs（药房福利管理者）在内的利益相关者需要支持。这表明教育不仅仅是针对患者，而是需要多方（Multi-stakeholder）共同努力来解决不同群体的担忧，因此选项 B 是正确的。 1. F 2. F 3. F 4. T 5. T 2. 根据文章内容，判断下列陈述为“正确”（T）或“错误”（F）。 ____（1）“可互换性” designation（指定）对市场准入的影响，与其最初设定的目标保持一致。 ____（2）市场上存在多个生物类似药选择，会自动转化为患者更容易获得治疗。 ____（3）国际上使用生物类似药的经验，已有效消除了这些市场中医疗提供者的犹豫态度。 ____（4）药品福利管理机构（PBMs）对生物类似药可及性的影响，主要反映了更广泛的医疗体系低效问题。 ____（5）成功推广生物类似药，必须同时解决心理层面和结构性障碍。 答案解析： (1) The interchangeability designation’s impact on market access has been consistent with its originally intended purpose. 原文第 14 段提到： "An interchangeable designation requires additional switching studies, ensuring the same clinical outcomes upon interchange and was initially designed to simplify access and accelerate medication availability." 第 15 段又指出： "However, this designation has been under scrutiny, as demonstrated by the recent FDA draft guidance recommending removing it from the product’s prescribing information." 说明 “可互换” 认定的实际效果与最初 “简化获取、加快供应” 的目的并不一致，反而引发争议。 → F (2) The presence of multiple biosimilar options in the market automatically translates to improved patient access to treatment. 原文第 6 段： "Despite this influx, the adoption of biosimilars in the US has been unexpectedly slow. Factors including interchangeability designation, pharmacy benefit managers (PBMs) limiting access to the drugs, and a lack of knowledge and comfortability with biosimilars among providers and patients have made it difficult for biosimilars to flourish..." 第 19 段也提到 PBMs 的封锁限制了患者获取低价药。 说明 “有多个生物类似药选项” 并不自动等于 “患者更容易获得治疗”，还受政策、PBM、认知等障碍影响。 → F (3) International experience with biosimilars has effectively eliminated provider hesitancy in those markets. 原文第 22 段： "Although the adoption of biosimilars has been slower than anticipated in the US, they have long been established internationally. Despite this familiarity, prescriber confidence and knowledge gaps are still present outside the US, leading to uncertainty and misinformation." 说明即便在国际市场，处方医生的犹豫和认知差距依然存在，并未被消除。 → F (4) PBMs’ influence on biosimilar access is primarily a reflection of broader healthcare system inefficiencies. 原文第 13 段： "Challenges exist in accessing biosimilars within the US healthcare system and providers often follow insurance preferences due to system complexities." 第 19-21 段指出 PBMs 限制准入、阻碍竞争，而第 28 段提到国会正审视包括保险机构角色在内的医疗体系结构问题。 PBMs 的干预是美国医疗体系复杂性、结构低效的具体表现之一。 → T (5) The successful biosimilar adoption requires addressing both psychological and structural barriers simultaneously.心理 / 认知障碍：医患对安全性、转换的犹豫、反安慰剂效应、知识缺口（第 8、9、17、18、22 段）。结构 / 系统障碍：可互换性认定、PBM 限制、保险覆盖与处方集限制、监管与行政流程（第 6、13、14、19、28 段）。 文章强调需要同时加强教育（解决心理 / 认知）和改革体系结构（解决准入 / 政策）才能推动生物类似药普及。 → T ✅最终答案：FFFTT 1. interchangeability2. scrutinize3. obstruct align, irreversible, substitute, transparency, discrepancy, designation。 翻译： 可用单词：align（使一致；对齐）、irreversible（不可逆转的）、interchangeability（可互换性）、designation（指定；命名）、discrepancy（差异；不符）、substitute（替代品；代替）、prioritize（优先处理；重视）、scrutiny（仔细审查；监督）、transparent（透明的；公开的）、obstruction（阻碍；障碍物） （1）研究结果表明，生物类似药可以与其参照生物制剂可互换地使用，而不会影响疗效或安全性。 （2）监管机构在批准新药之前，会仔细审查制药公司提交的安全性数据。 （3）肿瘤会不可逆地阻断血管，导致缺血性病症，可能需要手术干预。 （4）为了验证这一假设，实验数据必须与临床前研究和临床观察结果一致。 （5）研究表明，细胞衰老过程的不可逆性导致了与年龄相关疾病的发展。 （6）植物基蛋白作为动物源蛋白在饮食干预中的可持续替代品，正受到越来越多的研究。 （7）医疗定价的透明度对于让患者就其治疗方案做出知情决策至关重要。 （8）研究发现，观察数据与对照临床试验结果之间存在差异，这引发了人们对前者可靠性的质疑。 （9）某些药物被指定为孤儿药，这使得它们能够加速审批流程以应对罕见疾病。 （10）在临床试验中优先考虑患者安全对于确保伦理标准和研究结果的完整性至关重要 1. D，2. A，3. C，4.B 5 6 7 8 9 10 D B A C D B 翻译 （1）研究人员对研发管线（in the pipeline）中的新型抗癌化合物感到兴奋，这些化合物已证明对耐药肿瘤类型有效。 A. at the crossroads（处于十字路口；面临抉择） B. in clinical application（在临床应用中） C. on the assembly line（在流水线上；大规模生产中） D. under active development（在积极研发中） （2）药物的自付费用（Out-of-pocket spending）大幅增加，引发了人们对患者可及性和可负担性的担忧。 A. Direct personal expenditure（个人直接支出） B. Out-of-wallet expenses（钱包外的花费，非正确表达） C. Cash-only costs（仅现金支付的费用，非准确对应） D. Uninsured medical fees（未投保的医疗费用，范围过窄） （3）提供有关治疗替代方案的全面信息，可增强知情决策（informed decision-making）**，并让患者在医疗旅程中更有自主权。 A. unbiased choices（无偏见的选择） B. expert-based determinations（基于专家的判断） C. evidence-based choices（基于证据的选择） D. professional judgment（专业判断） （4）由于结果矛盾和对方法学严谨性的担忧，关于膳食补充剂疗效的最新研究正受到严格审查（under scrutiny）**。 A. under surveillance（在监视下） B. subject to examination（接受检查；受审查） C. in the spotlight（处于聚光灯下；受关注） D. under construction（在建设中） （5）新药被证明能抑制病毒复制（inhibit the virus from replicating）**，从而降低患者感染的严重程度。 A. slow ... during growth（在生长过程中减慢……） B. reduce ... while spreading（传播时减少……，逻辑不符） C. block ... in development（在发育中阻断……，语义偏离） D. prevent ... from reproducing（阻止……繁殖/复制） （6）体内的慢性炎症可能由多种因素引起（包括自身免疫性疾病和持续性感染），使治疗策略复杂化（complicating treatment strategies）**。 A. contribute to（促成；导致） B. stem directly from（直接源于） C. result in（导致；造成） D. emerge alongside（与……同时出现） （7）倡导团体敦促监管机构采取严格政策（adopt stringent policies）**，以减轻制药行业行为对患者安全的长期影响。 A. urge ... to implement（敦促……实施） B. encourage ... to consider（鼓励……考虑） C. require ... to accept（要求……接受） D. allow ... to choose（允许……选择） （8）与基因组医学的最新进展保持一致（Aligning with）**，该研究框架纳入精准治疗策略，为个体患者量身定制干预措施。 A. Associated with（与……相关联） B. Overlapping with（与……重叠） C. Matching with（与……匹配；与……一致） D. Clashing with（与……冲突） （9）远程医疗平台越来越便于老年患者使用（accessible to elderly patients）**，使慢性疾病的远程监测成为可能。 A. applicable to（适用于） B. familiar to（为……所熟悉） C. additive to（对……有加成作用） D. within reach of（在……可及范围内；为……所能获得） （10）研究人员已开始用人体器官芯片技术替代动物模型（substitute animal models for human organ-on-a-chip technologies）**，以更好地预测药物反应并减少伦理担忧。 A. transform ... into（把……转变成） B. replace ... with（用……替换……） C. convert ... to（把……转换为） D. change ... through（通过……改变） Biosimilars are a class of drugs characterized by lower research and development risks, higher technological barriers, and greater profit margins. Although China’s biosimilar industry started relatively late, it has experienced rapid growth in recent years, with over a hundred products currently in the pipeline. According to the latest industry data, since the National Medical Products Administration approved the first biosimilar, rituximab, in February 2019, China has approved 14 biosimilar products under the new registration classification (excluding insulin products) to date. Among these, several biosimilars developed by Chinese companies have successfully obtained approval in markets such as Europe and the United States. According to IQVIA forecasts, by 2027, as relevant biologic drugs globally reach patent cliffs, biosimilars are expected to contribute a significant market share. For Chinese pharmaceutical companies, overseas markets such as Europe and the United States present broad prospects for biosimilars. Expanding globally to pursue higher returns will drive considerable growth for their businesses.Unit4 Chronic Disease Management（1）单词 PPT文章标红 英文 中文翻译 简要解析 Nutrients 营养素；营养物质 食物中维持生命、生长的必需成分 Translate to 转化为；意味着；等同于 侧重 “从一种状态 / 结果变为另一种” at best 充其量；往最好里说 表示最乐观的估计，常带无奈语气 shortfall 缺口；不足；短缺 多指数量、资金、需求未达标 culprit 罪魁祸首；问题的起因 本义 “罪犯”，常用来指造成问题的原因 cries for 迫切需要；亟需 cry for sth = 强烈要求、急需 momentum 势头；动力；动量 指发展、运动、趋势不断加快的力量 alternative 替代品；备选方案；替代的 可作名词 / 形容词，指 “另一种选择” Culinary medicine 烹饪医学 把饮食、烹饪与医学治疗结合的学科 sparking interest 激发兴趣；引起关注 spark = 点燃、引发 Experiential learning 体验式学习 通过实践、亲身经历来学习 traction 吸引力；认可度；发展势头 指想法 / 产品被接受、开始见效 pivot 转变；转向；核心支点 指方向、策略、重点的重大调整 blends … with 将…… 与…… 融合 blend A with B = 把 A 和 B 混合 / 结合 legacy of … 的遗产；遗留影响 既可指物质遗产，也指精神、历史影响 gaining momentum 势头渐起；加速发展 越来越受欢迎、越来越有力量 a lag time 滞后时间；延迟期 行动与效果之间的间隔 convened 召集；召开（会议） 正式用语，convene a meeting 召开会议 accreditation 认证；资质认定 机构、项目获得官方认可 "It was music to my ears" 这真是悦耳之音；正中下怀 习语：听到非常想听、满意的话 core competencies 核心能力；核心竞争力 最关键、不可替代的能力 chorus 合唱；齐声；异口同声 a chorus of protest 一片抗议声 board certified 委员会认证的；持证执业的 多指医师通过专业委员会认证 looms over 笼罩；逼近；阴云笼罩 多指威胁、问题悬在头上 shoehorned 被强行塞入；牵强安排 把不合适的东西硬塞进去 tap into 利用；发掘；接入 tap into potential /resources 挖掘潜力 array 一系列；大批；阵列 an array of 一系列、各种各样 curating 策划；精心挑选；管理 原指策展，现指用心筛选整理内容 dispense 分发；配药；实施 dispense medicine 发药；dispense advice 提建议 scooping up 迅速获取；抢先拿下；抱起 快速、干脆地收集或收购 Punting 拖延；推诿；放弃 非正式，指把问题推走、不做决定 Given（句首） 考虑到；鉴于 引导条件或前提：Given that… delve into 深入研究；探究 深入挖掘细节、根源 distils 提炼；浓缩；吸取精华 从复杂信息中提取核心 synthesizing 综合；整合；合成 将多部分信息合为整体 forging 锻造；打造；建立 forge a relationship /path 建立关系、开辟道路（2）Text 1原文 How Nutrition Education for Doctors Is Evolving医生营养教育如何发展 课前原文内容总结： 这篇文章探讨了医学教育中营养学培训的现状、挑战与发展趋势。主要内容总结如下： 1. 现状与问题 ·医学教育长期忽视营养学，课程平均仅约11小时，且内容多聚焦生化知识，难以应用于临床。 ·营养学与疾病预防、治疗密切相关，但医生缺乏相关培训，导致临床指导能力不足。 2. 变革趋势 ·课程整合：倡导将营养学融入解剖、生理、药理等核心课程。 ·创新教学：引入“烹饪医学”等体验式学习，帮助医生掌握与患者讨论饮食的实用技能。 ·跨领域拓展：“生活方式医学”兴起，将营养与运动、减压等结合，强化疾病预防视角。 3. 系统性推动 ·美国国会2022年通过决议，呼吁重视医学营养教育。 ·医学认证机构首次召开专题会议，探讨制定营养学核心能力标准。 4. 挑战与协作 ·医生时间有限，无法替代注册营养师（RD）的专业角色。RD在个性化饮食计划、文化饮食适配、药物与食物相互作用等方面具有专长。 ·未来方向在于加强跨学科合作：医生需具备基础营养知识并识别其重要性，同时与营养专家协同，为患者提供全面照护。 核心结论：医学营养教育正从边缘走向整合，目标并非将医生变为营养师，而是使其理解“食物即良药”，并通过团队协作弥补知识缺口，从根源上改善疾病预防与治疗。 1 Dr. Jaclyn Albin still recalls learning about nutritional biochemistry while she was a student at the George Washington University School of Medicine & Health Sciences. But by the time she graduated in 2009, nutrition’s relevance to disease states and patient care hadn’t been addressed. 雅克琳·阿尔宾医生至今仍记得她在乔治·华盛顿大学医学与健康科学院就读时学习营养生物化学的经历。但直到2009年毕业时，营养学与疾病状态及患者护理的关联性仍未得到充分探讨。 2 “Historically, nutrition education has been mostly rooted in biochemistry, pathology, and physiology with nutrient-focused content,” says Albin, who’s now an internist and pediatrician in Texas. “For example, we would learn about vitamin C and how it impacts various pathways in the body, as well as what deficiency might look like. These things are important, but students then struggle to relate this to patient care. It’s challenging to translate education hyper-focused on nutrients to the real-life questions a patient may have about food.”  3 That’s similar to what Dr. Milan Shah, a urologist in Los Angeles, experienced when he attended the University of Pennsylvania, graduating in 2013. He says his medical education was excellent in terms of physiology and pharmacology, but nutrition training was introductory at best.  阿尔宾医生（现为德克萨斯州一名内科兼儿科医生）指出："从历史上看，营养学教育大多植根于生物化学、病理学和生理学，内容以营养素为核心。例如，我们会学习维生素C及其对人体各通路的影响，以及缺乏症的表现。这些知识固然重要，但学生往往难以将其与临床护理联系起来。将过度聚焦于营养素的教育，转化为患者可能提出的现实饮食问题，是极具挑战性的。"  洛杉矶泌尿科医生米兰·沙阿博士在宾夕法尼亚大学求学时（2013年毕业）也有类似经历。他表示，自己的医学教育在生理学和药理学方面非常出色，但营养学培训最多只能算入门级别。 4 “This is a concern, because nutrition training for physicians is extremely important but grossly undervalued,” he says. For example, in his specialty, nutrition can play a significant role in urologic health, which is why he’s spent considerable time researching the topic on his own, so he can discuss nutrition with his patients. But he would have liked to have had a more comprehensive approach from the start.  5 “Nutrition should be thoroughly integrated into the study of anatomy, physiology, and pharmacology, which will not only serve to educate future physicians but will also lead to more research,” he says. “Most of all, it will affect the treatment of patients.”  "这令人担忧，因为医师的营养学培训极其重要，却严重被低估，"他说道。以他的专业领域为例，营养在泌尿系统健康中扮演着重要角色，这正是他花费大量时间自主研究该主题的原因——以便能与患者讨论营养问题。但他更希望从一开始就能接受更系统的营养学教育。  他强调："营养学应当彻底融入解剖学、生理学和药理学的研究中，这不仅能培养未来的医生，还将推动更多相关研究。最重要的是，它将直接影响对患者的治疗方案。" 6 Anecdotes like these are common among physicians, even those who are recent graduates. Although nutrition education varies by school, a 2021 survey of medical schools in the U.S. and U.K., published in the Journal of Human Nutrition and Dietetics, found that most students receive an average of 11 hours of nutrition training throughout an entire medical program. Part of this training is typically student-run, and it may include culinary classes.  7 Attention has centered on this shortfall for decades. In 1985, the National Academy of Sciences recommended at least 25 hours of nutrition education in medical school, but a survey of U.S. medical schools in 2010 found that only 27% of programs met that recommendation. Lack of interest isn’t always the culprit, Albin notes.  ü 这类事例在医生中很常见，即使是近期毕业的医生也不例外。尽管各医学院的营养学教育存在差异，但2021年发表于《人类营养与饮食学杂志》的一项针对英美医学院的调查发现，绝大多数学生在整个医学教育过程中平均仅接受11小时的营养学培训。这部分培训通常由学生自主组织，可能包括烹饪课程。 ü 数十年来,人们的关注点一直集中在这一不足上。1985年,美国国家科学院建议医学院的课程至少应包含25小时的营养教育,但2010年对美国医学院的一项调查发现,只有27%的课程项目达到了该建议标准。阿尔宾指出,缺乏兴趣并非总是主因。 8 “Over the past two to three decades, passionate nutrition experts have tried a number of strategies to advance nutrition education without a lot of success,” she says. “This is largely due to lack of funding, broad support, and agreement about how much it matters. Experts have published cries for more attention to this vital issue, but we haven’t seen momentum until quite recently.” 9 Although research indicates that nutrition training is limited in scope and duration at many medical schools, there are indications that attitudes – and in some cases, curriculum – may be changing  她表示："过去二三十年间，满怀热情的营养学专家尝试了多种策略推进营养学教育，但收效甚微。这主要源于资金不足、缺乏广泛支持，以及对营养学重要性的共识不足。专家们曾多次发文呼吁各界重视这一关键议题，但直到最近才出现转变的势头。"  尽管研究显示许多医学院的营养学培训在广度和时长上仍受限，但有迹象表明人们的观念——以及部分课程设置——正在发生变化。 10 For example, Albin is director of UT Southwestern Medical Center’s culinary medicine program, which offers online modules for students and practicing physicians to learn about nutrition and understand how to apply that education to patient scenarios. Doctors should learn to advise patients on using food either as an alternative to or in combination with supplements, while also addressing food allergies in meal preparation. Culinary medicine, in general, has been sparking interest as a popular elective at a number of prominent schools, Albin adds, including her alma mater, George Washington University. “Experiential learning in a teaching kitchen builds not only nutrition knowledge, but also provides a way to discuss food with patients,” Albin says.  例如，阿尔宾担任德克萨斯大学西南医学中心烹饪医学项目主任，该项目通过在线模块帮助学生和执业医师学习营养知识，并掌握如何将其应用于临床场景。医生应当学会指导患者,将食物作为膳食补充剂的替代品或搭配品来使用,同时在膳食准备中注意处理食物过敏问题。阿尔宾补充说,总体而言,烹饪医学作为一门热门选修课,已在包括她的母校乔治华盛顿大学在内的多所知名院校引发了广泛兴趣。阿尔宾表示:“在教学厨房中进行体验式学习,不仅能巩固营养学知识,还为医患之间探讨饮食问题提供了一种有效方式。 11 Examining nutrition within a larger context is another promising step forward, says Dr. Raja Jaber, a family medicine physician at Stony Brook Family and Preventive Medicine in New York. Most notably, she highlights that lifestyle medicine is gaining traction in medical education coursework. Such an approach blends nutrition with other components of a healthy life, like stress reduction, social support, and physical activity. That’s part of a larger pivot in how doctors are being trained. It’s taking time to manifest, but it could have meaningful results for patients – and for how physicians care for their own health, potentially reducing burnout and helping doctors model healthy habits, Jaber says. 纽约石溪大学家庭与预防医学系家庭医生拉贾·贾伯博士指出，在更宏大的背景下审视营养学是另一项值得期待的进展。她强调,生活方式医学在医学教育课程中越来越受到关注。这种方法将营养与健康生活的其他要素相结合,如减压、社会支持和体育活动。这是医生培养方式更大转变的一部分。贾伯表示，这种转变需要时间方能显现成效，但它可能为患者带来实质性益处，并改善医生对自身健康的管理，从而可能缓解职业倦怠，帮助医生树立健康行为典范。 12 “The present state of nutrition education in our medical schools is sad,” she adds. “It’s part of a legacy of a treatment model based on pharmacology and surgery. But the emphasis on prevention and lifestyle is gaining momentum, due to many studies showing the impact of lifestyle modifications on the prevention of chronic disease.” However, Jaber notes, there’s always a lag time between science and its applications. One possible push toward shortening that delay may be legislative action and more attention from government as well as medical education leaders. In May 2022, a bipartisan resolution authored by Congressmen James McGovern (D-MA) and Dr. Michael C. Burgess (R-TX) passed the U.S. House of Representatives. It highlights the need to prioritize and advance nutrition education in medicine. Prior to the resolution’s passage, McGovern said on the House floor that “we cannot continue to ignore the correlations between diet and health.”  我们医学院目前的营养学教育状况令人遗憾,”她补充道,“这源于一个以药理学和外科手术为基础的治疗模式传统。但是,由于大量研究显示了生活方式调整对预防慢性病的影响,重视预防和生活医学的理念势头正盛。”然而,贾伯指出,从科学到应用之间总是存在滞后时间。缩短这一滞后的可能性,有赖于立法行动的推进,以及政府和医学教育领导者更多的重视。2022年5月，由众议员詹姆斯·麦戈文（马萨诸塞州民主党人）和迈克尔·C·伯吉斯博士（德克萨斯州共和党人）提出的两党决议在美国众议院获得通过。该决议强调必须优先推进医学领域的营养学教育。决议通过前，麦戈文在众议院发言表示："我们不能继续忽视饮食与健康之间的关联。" 13 In September 2022, the White House Conference on Hunger, Nutrition, and Health focused on what’s needed to address food-related disease and disparities. One of its pillars is to prioritize the role of nutrition and food security in overall health, including disease prevention and management, noting that the health care system should play a significant role in that effort.  14 More recently, in early March, leaders across the governing bodies of medical education and practice convened at a summit in Chicago, which Albin says is the first time that medical board and accreditation groups formally discussed the topic. “It was music to my ears to hear the chorus of agreement on the problems, barriers, and need to develop core competencies in nutrition across the medical education continuum,” she says.   2022年9月，白宫饥饿、营养与健康会议聚焦于应对饮食相关疾病和健康差异所需的措施。其核心支柱之一是强调营养和粮食安全在整体健康（包括疾病预防和管理）中的关键作用，并指出医疗系统应在此过程中发挥重要作用。  最近,三月初,医学教育与实践各管理机构负责人齐聚芝加哥参加了一次峰会。阿尔宾称,这是医学委员会和认证机构首次正式讨论这一议题。"听到大家异口同声地认同其中存在的问题、障碍,以及有必要在整个医学教育连续体中培养营养学核心能力, 这真让我欣喜不已,“她说道。 15 While medical students in the future may benefit from these changes, some physicians are taking a more active role in educating themselves. For example, Dr. Lauren Lemieux remembers having only one lecture on vitamin deficiencies before graduating from the University of California-Irvine in 2015. But a lifelong passion for nutrition and its impact on health led her to do a residency in clinical nutrition at UCLA. She’s now board certified as a physician nutrition specialist, in addition to certifications in internal medicine and obesity medicine. Although she was happy to put in the time and effort to focus on nutrition, she admits it would have been ideal if the topic was part of the medical school curriculum.  尽管未来的医学生可能受益于这些改革，但一些医生正更积极地开展自我教育。例如，劳伦·勒米厄医生回忆2015年从加州大学尔湾分校毕业前，仅听过一次关于维生素缺乏症的讲座。但对营养学及其健康影响的长久热情，促使她在加州大学洛杉矶分校完成了临床营养学住院医师培训。如今她除了拥有内科和肥胖医学认证外，还获得了医师营养专家的委员会认证。尽管她乐于投入时间精力专攻营养学，但她也承认，如果这个主题能成为医学院课程的一部分会更理想。 16 “Unfortunately, as most doctors get little training in nutrition during their medical education and beyond, many find themselves ill-prepared to provide evidence-based nutritional recommendations to their patients,” she says. “It would be wonderful for students to get exposed to nutrition early on and receive training from experts who can teach practical, clinically applicable skills related to nutritional counseling.” 17 Because of the importance of nutrition for preventing chronic disease and improving many treatment regimens, understanding how food choices affect health is crucial. However, one major question looms over whether physicians actually need extensive training: How realistic is it to expect doctors to master a subject that registered dietitians (RDs) spend at least four years learning about?  她说："遗憾的是，由于大多数医生在医学教育阶段及后续培训中接触的营养学训练很少，很多人发现自己难以向患者提供循证营养建议。如果学生能尽早接触营养学，并接受能教授实用、临床适用营养咨询技能的专家培训，那将非常有意义。"  鉴于营养学对预防慢性病和改进治疗方案的重要性，理解饮食选择如何影响健康至关重要。但一个核心问题浮现：是否真有必要对医生进行广泛培训？期望医生掌握注册营养师（RD）至少需四年学习的内容是否现实？ 18 Conversations with patients are already limited by factors like time restrictions, and adding the type of comprehensive and personalized recommendations necessary for meaningful nutritional changes can rarely be shoehorned into a few minutes. Plus, even patients who discuss nutrition with their doctor will often need to meet with an RD to tap into a wide array of services. 19 In addition to curating meal plans, RDs provide insights related to cultural factors around food choices, and can dispense nutrition advice for those dealing with an eating disorder or another specific condition. “We’re providing medical nutrition therapy, counseling patients and physicians, working with home health care agencies, working with insurance on getting special formulas approved for patients, and talking about food safety,” says Dana Hunnes, a senior clinical registered dietitian at UCLA Medical Center. “We’re not just scooping up food in the hospital kitchen; we’re the experts in all things nutrition.”  与患者的交流本就受时间限制等因素制约，而实现有意义的饮食改变需要全面且个性化的建议，很难压缩在几分钟内完成。此外，即使与医生讨论过营养问题的患者，通常仍需咨询注册营养师以获得更广泛服务。  除了定制膳食计划，注册营养师还能提供饮食选择中的文化因素解读，并为饮食失调或其他特定状况者提供专业建议。"我们提供医学营养治疗，为患者和医生提供咨询，与家庭保健机构合作，与保险公司沟通批准患者特殊配方食品，并指导食品安全，"加州大学洛杉矶分校医学中心高级临床注册营养师达娜·亨尼斯说，"我们不只是医院厨房的配餐员，我们是营养领域的全方位专家。" 20 Should a surgeon have detailed knowledge of protein requirements for a patient who’s recovering after a gastrointestinal procedure and needs nutrition through an IV? What about an internal medicine physician whose patient is Muslim and follows halal practices, but needs a new eating plan for reducing blood pressure and high cholesterol? There’s also complexity around how certain foods interact negatively with medications, potentially preventing a drug from working the way it should, or worsening the side effects. 21 These are all topics that RDs cover extensively, Hunnes says. Expecting medical education to dive deeply into these considerations, even though they’re a crucial part of care, may be unrealistic. That doesn’t mean punting all nutrition-based decisions to clinical nutrition professionals, but it could offer patients a wider range of insights to make up for any knowledge gaps on the topic within a healthcare team.  外科医生是否需要详细了解胃肠道手术后需静脉营养支持患者的蛋白质需求？内科医生面对遵循清真饮食的穆斯林患者，在制定降血压、降胆固醇饮食方案时应如何考量？某些食物与药物的负面相互作用也涉及复杂知识，可能影响药效或加剧副作用。  亨尼斯指出，这些都是注册营养师深入研究的领域。期望医学教育深度涵盖这些内容（尽管它们是诊疗的关键部分）可能不切实际。这并非意味着将所有营养决策推给临床营养专家，但可以弥补医疗团队在该领域的知识盲区，为患者提供更全面的见解。 22 Given the depth and breadth of nutrition’s contribution to medicine, an increase in  physician training may be advantageous for many patient conversations, but perhaps the most useful aspect of that education would be recognition of nutrition’s importance – and how that may include increased collaboration with RDs and other nutrition specialists.  23 “The issue of nutrition is frequently put off if doctors only have 20 minutes to complete an annual checkup,” says Dr. Denise Pate, medical director with Medical Offices of Manhattan, a group of primary-care doctors. “I believe that multidisciplinary collaboration is crucial. Physicians must be made aware of the value of nutritional knowledge, and working with a trained dietitian is essential.”   鉴于营养学对医学贡献的深度和广度，加强医师培训可能有助于提升医患沟通质量。但此类教育最有价值的方面或许是让医生认识到营养学的重要性——包括如何加强与注册营养师及其他营养专家的协作。  曼哈顿医疗中心（一家初级保健医生集团）医疗主任丹尼斯·佩特医生表示："如果医生只有20分钟完成年度体检，营养问题经常被搁置。我认为多学科协作至关重要。必须让医生认识到营养知识的价值，与训练有素的营养师合作更是必不可少。" 24 The bottom line is that there are many aspects of healthy lifestyle habits that aren’t covered extensively in most medical education programs. For example, how much do physicians really learn about prescribing a specific exercise regimen based on the fitness level of each patient, or delve into the nervous system improvements achieved with meditation? In many ways, nutrition falls into this category as well, Pate says.  25 As with most medical challenges, the solution distils down to synthesizing multiple strategies: enhancing nutritional science in medical curricula, and forging interdisciplinary partnerships between clinicians and specialists in nutrition science, integrative medicine, and lifestyle therapies.  26 “It’s important to note that we are not trying to make doctors become dietitians, but rather to understand that our neglect of this topic has done harm and led to a very poor understanding of the underlying root causes of many diseases such as poor quality food,” Albin says. “We must move past this and prepare the next generation to prescribe food as medicine.”  关键在于，大多数医学教育项目未能全面涵盖健康生活方式的诸多方面。例如，医生究竟学过多少关于根据患者个体健康水平制定运动处方的知识？或深入研究冥想对神经系统的改善作用？佩特指出，在许多方面，营养学也属于这类被忽视的领域。  正如应对多数医学挑战，解决方案归结为综合多种策略：加强医学课程中的营养科学教育，促进临床医生与营养科学、整合医学及生活方式治疗专家之间的跨学科合作。  阿尔宾总结道："必须明确，我们并非要把医生培养成营养师，而是要认识到忽视这个议题已造成危害，导致许多疾病（如劣质食品引发的疾病）的根本成因未被充分理解。我们必须超越现状，培养新一代医生'以食为药'的处方能力。"（3）课后练习 翻译 1. 请根据文章选择最佳答案（A、B、C 或 D）。 (1) Milan Shah 医生和 Jaclyn Albin 医生所接受的医学教育的相似之处是什么？ A.他们具备扎实的营养知识应用基础。 B.他们认识到维生素C缺乏与患者护理之间的关联。 C.他们熟悉营养专业知识在护理患者中的实际应用。 D.他们受过生理学培训，但所接受的营养学教育仅是基础性的。 (2) 作者引用了《人类营养与饮食学杂志》2021年的一项调查结果，目的是为了 _____。 A.举例说明营养培训与烹饪课程的有效结合 B.说明医学课程中营养培训的不足 C.强调由学生主导的营养培训的重要性 D.展示营养培训在医疗保健中发挥的重要作用 (3) 根据文章，在营养和生活方式医学方面，缩短科学与应用之间延迟的可能解决方案是什么？ A.采取立法行动并引起领导者的关注。 B.展示生活方式改变对疾病预防的影响。 C.在真实场景中建立体验式学习。 D.将营养教育与其他健康生活组成部分相结合。 (4) 以下哪项陈述不是注册营养师的工作职责描述？ A.为患者提供医学营养疗法。 B.警惕关于食物选择的文化禁忌。 C.追踪保险公司认可的特殊食品。 D.持续监测处方药的剂量。 (5) 在文章第20段中引用一系列问题的目的是 _____。 A.阐明掌握临床营养学对外科医生的重要性 B.揭示当前医学教育存在的缺陷 C.强调期望医学教育解决所有问题是谬误 D.表明营养学对医学贡献的深度和广度 答案 1. **D** 解析：两人都接受了生理学等专业训练，但营养学培训都很基础、仅入门水平。 2. **B** 解析：引用2021年调查是为了说明医学院营养学培训时长严重不足。 3. **A** 解析：文中提到通过立法行动、政府及医学教育领导层重视，可缩短科研到应用的滞后。 4. **D** 解析：监测药物剂量是医生职责，不是注册营养师（RD）的工作内容。 5. **C** 解析：一连串问题是为了强调，指望医学院包揽所有复杂营养问题是不现实、不合理的。 翻译： 2. 请根据文章判断以下陈述是正确 (T) 还是错误 (F)。 (1) 医学院的营养教育历来侧重于患者护理的实际应用。 (2) 在大多数医学院，对医生的营养培训一直未得到足够重视。 (3) 生活方式医学只有在帮助患者减轻压力方面才能产生有意义的成果。 (4) 期望医生精通营养师至少需要学习四年的科目是不现实的。 (5) 将所有基于营养的决策交给临床营养专业人士是合理的，因为他们能为患者提供广泛的见解。 答案： (1) **F** 解析：传统营养教育侧重营养素、生化理论，**并非**临床实际应用。 (2) **T** 解析：文中明确指出医师营养培训“extremely important but grossly undervalued”。 (3) **F** 解析：生活方式医学不仅对患者有益，也能帮助医生缓解职业倦怠、树立健康习惯，并非只对患者、只针对减压。 (4) **T** 解析：原文明确提出“How realistic is it to expect doctors to master a subject that registered dietitians spend at least four years learning about?”，并暗示这不现实。 (5) **F** 解析：文中说“That doesn’t mean punting all nutrition-based decisions to clinical nutrition professionals”，即不应把所有营养相关决策都推给营养师。 翻译： 1. 请用下面提供的恰当单词完成下列句子。必要时改变单词形式。 单词选项： deficiency（缺乏，不足） | culprit（罪魁祸首，问题的根源） | dietitian（营养师） | accreditation（认证，认可） | convene（召集，召开） loom（逼近，隐现） | dispense（分发，配给） | delve（深入研究，探究） | distil（提炼，浓缩，蒸馏） | pivot（以……为枢纽，关键转折点） 句子翻译与填空解析： (1)Dietitians contribute to clinical trials by analyzing how micronutrient interventions affect metabolic syndrome biomarkers. 营养师通过分析微量营养素干预如何影响代谢综合征生物标志物来参与临床试验。 (2) The discovery of the new biomarker was a pivotal moment in the development of targeted therapies for breast cancer. 新生物标志物的发现是乳腺癌靶向治疗发展中的一个关键时刻。（pivot → pivotal，形容词修饰moment） (3) To better understand the epidemiology of the outbreak, scientists delvedinto the patterns of disease transmission in the affected regions. 为了更好地理解疫情的流行病学，科学家们深入探究了受影响地区的疾病传播模式。（delve → delved，过去式） (4) The patient’s symptoms of fatigue and weakness were attributed to a severe deficiencyof vitamin B12, necessitating immediate supplementation. 患者疲劳和虚弱的症状归因于严重的维生素B12缺乏，需要立即补充。 (5) In response to the rising incidence of antibiotic resistance, an international summit was convened to discuss potential solutions and policy changes. 为应对抗生素耐药性发病率上升，一次国际峰会被召集来讨论潜在解决方案和政策变化。（convene → convened，被动语态） (6) The review article distils the current knowledge on the pathophysiology of Alzheimer’s disease into an accessible format for healthcare professionals. 这篇综述文章将当前关于阿尔茨海默病病理生理学的知识浓缩成医疗专业人员易于理解的格式。（distil → distils，第三人称单数） (7) Environmental factors, such as prolonged exposure to pollutants, were identified as the culprit for the increased incidence of respiratory diseases in the region. 环境因素，例如长期暴露于污染物中，被认定为该地区呼吸道疾病发病率上升的罪魁祸首。 (8) Medical residency programs lose accreditation if they fail to meet minimum training hour requirements. 如果住院医师项目未能达到最低培训小时要求，就会失去认证。 (9) The threat of a new influenza pandemic looms / loomed large, prompting health officials to enhance surveillance and preparedness measures. 新型流感大流行的威胁迫在眉睫，促使卫生官员加强监测和准备措施。（loom → looms，第三人称单数）（loom 变为一般现在时 looms 或过去式 loomed，loom large 表示“逼近、显得严峻”） (10) In the context of palliative care, the ability to dispense controlled substances in a timely manner can be crucial for managing severe pain and ensuring patient comfort. 在姑息治疗的背景下，及时配给受控物质的能力对于管理剧烈疼痛和确保患者舒适至关重要。 ACADA 翻译 (1)这种新药治疗晚期癌症的疗效充其量是有限的，临床试验显示总体生存率仅有轻微提高。 A.至少 B.在理想情况下 C.无论如何 D.最低限度 (2)关于常规乳腺X光筛查有效性的争论围绕乳腺癌早期发现与过度诊断和过度治疗的潜在风险之间的平衡展开。 A.偏离 B.使分心 C.围绕 D.散布 (3)该研究涉及的伦理考量范围广泛，涵盖了患者知情同意、数据隐私和潜在利益冲突等问题。 A.范围广泛 B.超出范围 C.范围有限 D.范围受限 (4)可穿戴健康技术，如连续血糖监测仪和健身追踪器，因其改善慢性病管理的潜力，正在患者和医疗保健提供者中获得认可。 A.失宠 B.遭遇反对 C.面临阻力 D.获得认可 (5) 20世纪广泛开展的疫苗接种运动催生了群体免疫力，显著降低了全球传染病的发病率。 A.导致了…的产生 B.造成了…的缺乏 C.保持了…的衰退 D.保持了…的侵蚀 1. **A** **解析**：短语 **at best** 意为“充其量、至多、往最好里说”，与选项 A **at the very least**（至少，往最坏处想/最低限度）在语境中表达最接近。B选项指“在理想情况下”；C指“无论如何”；D指“在最低程度上”，均不符合原意。 2. **C** **解析**：短语 **center on**意为“以……为中心、围绕……展开”。选项 C **revolves around** 意为“围绕……旋转/以此为中心”，两者语义完全一致。A、B意为“转移注意力”；D为错误搭配。 3. **A** **解析**：短语 **extensive in scope** 意为“范围广泛的”。选项 A **wide in range** 意为“范围广泛的”，语义相符。B意为“超出范围/不相关”；C、D意为“范围有限的”，与原意相反。 4. **D** **解析**：短语 **gaining traction** 意为“越来越受欢迎、获得认可/普及”。选项 D **obtaining acceptance** 意为“获得接受”，精准对应。A、B、C均表示“不受欢迎/遭到反对”，意思相反。 5. **A** **解析**：短语 **left a legacy of** 意为“留下了……的遗产/造就了……的局面”。选项 A **given rise to** 意为“引起、导致、使发生”，在此语境下能准确表达“造就了群体免疫这一成果”的含义。B表示“导致缺乏”；C、D搭配和语义均不符。 BADBC 翻译 (6)在考虑慢性疼痛的各种治疗方案时，根本要点始终是以患者为中心的方法在疼痛管理和生活质量方面能带来最佳结果。 A.次要考虑 B.核心事实 C.争议点 D.次要方面 (7)干细胞疗法的潜力巨大，因为它能够利用人体的自然再生过程来治疗多种退行性疾病。 A.利用 B.干扰 C.抛弃 D.用尽 (8)由于该遗传病的罕见性和复杂性，儿科医生选择将该病例转诊给遗传学家，以便进行更全面的分析并制定管理计划。 A.与…互动 B.与…合作 C.与…商议 D.转诊给 (9)长期暴露于慢性压力下的个体，由于应激反应系统的持续激活，更容易出现一系列健康问题，包括心血管疾病和精神健康障碍。 A.免受 B.遭受 C.免受 D.习惯于 (10)关于使用可穿戴技术进行持续血糖监测的试点研究取得的良好结果，激起了人们对其在管理不同人群糖尿病方面应用的兴趣。 A.干扰了热情 B.转移了注意力 C.激发了热情 D.降低了兴奋度 答案 (6) B. the essential fact 解析："the bottom line" 在此处指“最基本的事实/关键点”，强调以患者为中心的治疗方法最为重要，与 B 选项含义一致。 (7) A. make use of 解析："tap into" 意为“利用、开发”，与 A 选项"make use of" 同义。 (8) D. refer ... to 解析："punt the case to" 是口语化表达，指“将（难题）转交给”，在医疗语境中相当于将患者转诊给专科医生，与 D 选项"refer ... to" 同义。 (9) B. subjected to 解析："exposed to" 在此处意为“长期处于…之下”，与 B 选项"subjected to"（经受、遭受）含义最接近。 (10) C. generated enthusiasm 解析："sparked interest" 意为“引发兴趣”，与 C 选项"generated enthusiasm"（产生热情）意义一致。 翻译 “良药苦口”是一句古训，以此形容治疗疾病所使用的药物有时味道苦涩，难以下咽。然而，随着对中医药膳文化的重视和发展，医学与烹饪的结合将这句古训重新演绎，让“药膳可口”成为了可能。在传统药膳概念的大背景下，医学和烹饪结合起来，开创出全新的治疗方式。通过药材配伍，不仅能够发挥出食材的药用价值，配合专业医学知识，也能够让人们在享用美味的同时获得健康滋养的药膳食谱。很多医院长期积极推广药膳文化，先后推出月子餐、糖尿病餐等特殊群体营养餐，均获得不错的反响，充分发挥了营养膳食的临床作用。 "Good medicine tastes bitter" is an ancient adage, used to describe how the medicines used to treat diseases are sometimes bitter and hard to swallow. However, with the growing appreciation and development of medicinal cuisine culture in traditional Chinese medicine, the combination of medicine and culinary arts has redefined this old saying, making "medicinal food palatable" a reality. Against the backdrop of the traditional concept of medicinal cuisine, the integration of medicine and cooking has pioneered an entirely new approach to treatment. Through the scientific combination of medicinal herbs, not only can the therapeutic value of ingredients be fully utilized, but when paired with professional medical knowledge, it also allows people to enjoy delicious meals while benefiting from the nourishing and health-promoting properties of medicinal recipes. Many hospitals have long been actively promoting the culture of medicinal cuisine, introducing special nutritional meals such as postpartum confinement meals and diabetic meals, all of which have received positive feedback, fully demonstrating the clinical role of therapeutic nutrition.

Fresenius Kabi introduces its first immunology biosimilar in the U.S. CMS grants Fresenius Kabi permanent, product-specific Q-Code for IDACIO ® (adalimumab-aacf) Commitment to the development of biologic treatments across multiple therapeutic targets in immunology through an expanded pipeline LAKE ZURICH, IL, USA I July 03, 2023 I Fresenius Kabi announced today the immediate availability in the U.S. of its citrate-free adalimumab biosimilar IDACIO ® (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira ® (adalimumab). IDACIO ® is available in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector). “We are thrilled to launch IDACIO, our first immunology biosimilar in the U.S.,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases.” An IDACIO ® branded biosimilar is available in more than 35 countries.* IDACIO ® (adalimumab-aacf) is indicated for reducing signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis in adults and plaque psoriasis. The Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for IDACIO ® (adalimumab-aacf) . Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to IDACIO ® is effective for patients administered IDACIO on and after July 1, 2023. The new code for IDACIO ® is Q 5131. To learn more about how Fresenius Kabi provides comprehensive patient support for IDACIO ® please click here . IDACIO ® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira ® (adalimumab). Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. Q-codes are permanent reimbursement codes granted to biosimilars and used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like IDACIO ® that are administered by a physician. Claims submission and documentation are simplified with a permanent Q-code, facilitating and streamlining the billing and reimbursement process. IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with IDACIO ® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue IDACIO ® if a patient develops a serious infection or sepsis. Reported infections include: Carefully consider the risks and benefits of treatment with IDACIO ® prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO ® , including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with IDACIO ® should not be initiated in patients with an active infection, including localized infections. Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue IDACIO ® if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with IDACIO ® , closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of adalimumab products with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of IDACIO ® and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including IDACIO ® , may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. In patients who develop HBV reactivation, stop IDACIO ® and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of IDACIO ® therapy in this situation and monitor patients closely. NEUROLOGICAL REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of IDACIO ® in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of IDACIO ® should be considered if any of these disorders develop. HEMATOLOGICAL REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping IDACIO ® if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on IDACIO ® should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating IDACIO ® therapy. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. INDICATIONS Please see IDACIO full Prescribing Information , including the BOXED WARNING. About IDACIO ® , an adalimumab biosimilar IDACIO ® (adalimumab-aacf), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira ® (adalimumab). Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. IDACIO ® has been developed by Fresenius Kabi SwissBioSim, using advanced analytical methods for use in the treatment of several chronic conditions including rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. About Fresenius Kabi Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at http://www.fresenius-kabi.com/us/join-us and follow us on LinkedIn . For more information about Fresenius Kabi biosimilars in the U.S., please visit https://biospecialized.com/ . *Citrate formulation, manufactured by a different process. SOURCE: Fresenius Kabi