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仿制药替代潜在最大费用节省研究 总被引:1,自引:0,他引:1
目的在仿制药替代背景下,比较原研药和仿制药的价格和采购量,测算仿制药替代的潜在最大费用节省,推动仿制药供应与使用。方法基于陕西省药品招标采购数据,选取2017年12月第一批通过仿制药质量和疗效一致性评价的17个品种(16个品规)药品,对其2017年至2018年的价格、采购量进行分析;采用成本分析法、推测预算法,对采购平台上该通用名、剂型的药品替换为通过仿制药质量和疗效一致性评价单价最低的仿制药,测算年均仿制药替代的潜在最大费用节省。结果价格由高到低依次为原研药、未通过一致性评价的仿制药、通过一致性评价的仿制药;采购量方面,5个品规药品的原研药采购量占比较高,11个品规药品的仿制药采购量占比较高,1个品规药品未发生仿制药替代;对16个品规药品进行仿制药替代后,测算出潜在最大费用节省为3243.63万元。结论仿制药替代可显著节省药品费用,我国的仿制药市场提升空间较大,后续应加快推进仿制药一致性评价和临床使用。 相似文献
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目的:为完善药品政府定价,特别是对于原研药的定价提供参考。方法:通过统计国家发改委药品定价目录中的价格数据,计算注射剂中原研药与仿制药价格的差价率。结果:满足《药品政府定价办法》中对于差价率规定(注射剂差价率35%)的药品仅占总数的26%,且最高的一个差价率超过500%。结论:建议政府采用逐步降价等较温和方法,控制给予原研药的价格优惠程度,并建立动态的价格调控机制,使原研药生产企业与仿制药生产企业利益趋于平衡。 相似文献
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目的:为完善我国仿制药一致性评价中参比制剂选择机制和程序提供参考,为仿制药企业在应用选择参比制剂时提供思路。方法:详细介绍了美国FDA有关参比制剂选择指南草案的最新描述,以及欧盟、日本和WHO对于参比制剂的相关要求。结合我国现阶段仿制药一致性评价工作实际,为完善参比制剂选择程序提出建议。结果与结论:美国详细规定了仿制药参比制剂的选择思路和实际操作程序,为我国仿制药参比制剂的选择提供了新的思路。我国正处于仿制药一致性评价参比制剂遴选的关键时期,制定全面、完善的参比制剂遴选体系和机制,有助于规范参比制剂的选择程序,加快一致性评价工作进程,提升我国仿制药一致性评价参比制剂选择的科学性和完整性。 相似文献
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目的 研究分析当前仿制药质量和疗效一致性评价的现状及存在问题,提出推进仿制药一致性评价的建议。方法 梳理并分析我国基本药物化学药品目录中口服固体制剂的品种情况、持有文号的生产企业情况、参比制剂公布情况及实施仿制药一致性评价中的问题。结果 低价药、独家品种开展一致性评价比例偏低,未来可及性风险不容忽视。结论 生产企业要落实评价主体责任,以提高质量作为企业发展要务;相关管理部门应加快出台激励政策,助推企业开展仿制药一致性评价。 相似文献
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《Saudi Pharmaceutical Journal》2022,30(9):1243-1251
Generic drugs or generic medicines are pharmaceutical products manufactured to be equivalent to the brand/innovator drug products. They represent the majority of worldwide prescribed medicines; therefore, their quality is critical to maximize patients’ therapeutic outcomes. This study aimed to evaluate the pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products being sold in the United Arab Emirates (UAE) market to enhance public confidence, promote their utilization, and reduce treatment costs. Three drugs (tadalafil, rosuvastatin, and acetaminophen) from three different pharmacological classes were selected from the UAE market as representatives for generic drugs. At least two generic products for each locally (L) and regionally (R) manufactured generic were evaluated according to the USP criteria in comparison to the brand (B) comparator product. All comparative tests were performed before storage and 3 and 6 months after storage during the accelerated stability study performed under the conditions for climatic zone IV (40 °C ± 2 °C /75% RH ± 5% RH). Although results were statistically different from the comparators using ANOVA and Tukey’s Kremer post hoc tests, all tests were within the USP acceptance limits, except one, for friability, disintegration, content uniformity, and dissolution. Significant changes were observed following their storage over 6 months during accelerated stability studies, however, without failing the USP limits. Only one locally manufactured acetaminophen generic failed the USP dissolution tests before and after its storage and failed the disintegration test following its storage under accelerated conditions for zone IV. In conclusion, the majority of the locally and regionally manufactured generic products being sold in the UAE market were of good quality and performed similarly to their comparators. However, a continuous independent quality evaluation for the marketed generic drugs is essential to enhance public confidence. 相似文献
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近年来,美国处方药市场中一个显著的新动向,即价格相对低廉的仿制药品的使用品种不断增加,患者用在药品上费用的支出不断减少。与此相反,使用价格昂贵的创新药物和新药的患者的数量大大减少(特别是治疗慢性病的药品)。这种趋势,即使用创新药物转向使用仿制药物十分强劲。由此看出,美国医改政策的一个侧面。 相似文献
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The 1984 Waxman-Hatch Act had two main objectives. Title I was designed to promote price competition by establishing an abbreviated new drug application (ANDA) process for generic market entry. Title II was designed to encourage drug innovation by restoring some of the patent life lost during the lengthy FDA regulatory process. In this paper, we consider whether these twin objectives have been realised during the first decade of the Act's existence. First, we investigate the pattern of generic and brand name prices and market shares for the major products whose patents expired between 1984 and 1993. A regression model indicates that generic competition has been intensifying significantly in recent periods. Major brand name products now typically lose more than half their market share within the first year after patent expiration. In addition, we examine changes in patent protection for new chemical entities introduced over the period 1984 to 1993. For 1991 to 1993 new drug introductions, the average effective patent life was 11.8 years with 2.3 years resulting from Waxman-Hatch extensions. In the final section of the paper, we consider how the US law compares with that in Europe and discuss possible legislative improvements in the 1984 Act. 相似文献
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Dentali F Donadini MP Clark N Crowther MA Garcia D Hylek E Witt DM Ageno W;Warfarin Associated Research Projects Other Endeavors 《Pharmacotherapy》2011,31(4):386-393
The use of generic drugs has become increasingly common in clinical practice. However, for drugs with a narrow therapeutic index, such as warfarin, there may be some concern regarding the definition of bioequivalence. Clinical studies that compared brand name and generic warfarin products provided conflicting results. Therefore, we performed a systematic review of the literature to better assess the characteristics of each generic warfarin product. Several sources were searched, including MEDLINE and EMBASE, electronic records of meetings' abstracts, and reference lists of included articles. Articles were considered relevant if they were original studies, enrolled patients receiving oral anticoagulant treatment, and compared any approved generic warfarin with brand name warfarin in at least one clinical, laboratory, or management outcome. Eleven studies, with a total of more than 40,000 patients, were included; five were randomized controlled trials, and six were observational studies. In three crossover trials evaluating the mean difference of the international normalized ratio (INR) after switching to the alternate formulation of warfarin, no statistically significant difference was found between patients randomly assigned to receive brand name or generic warfarin. The two other randomized trials found no significant differences in the magnitude or number of dosage changes between patients switched to brand name or generic warfarin. The results of the observational studies are more conflicting, suggesting different features for different generic warfarin products. In these observational studies, the time in the therapeutic range and the number of thromboembolic and hemorrhagic complications were similar in studies that compared the anticoagulation control before and after the switch to a generic warfarin product. In one observational study, however, a change in therapeutic INR control after the switch to generic warfarin was reported at the individual patient level. The results of our systematic review suggest that generic warfarin products may be as safe and effective as brand name products and that patients may be safely treated with these products. However, closer monitoring may be reasonable when switching brands, as variations in individual INR response may be seen. 相似文献
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Maria Kleinstäuber Sarah Colgan Keith J. Petrie 《Research in social & administrative pharmacy》2021,17(7):1288-1299
BackgroundGeneric medicines have been associated with less perceived efficacy and more side effects compared to brand name drugs. Educational interventions to improve individuals’ negative perceptions of generic medicines show contradictory effects.ObjectiveThis study investigated whether an interventional video that informs about the approval process of releasing medicines has better effects on outcomes related to perceptions and effectiveness of generic medicines in participants with headaches, in comparison with another interventional video that addresses bioequivalence between brand name and generic drugs or a control video.MethodsParticipants with frequent tension headaches were randomized to one of three groups (one of two interventional videos or the control video). One of the interventional videos explained the process of approval of generic medicines (n = 34), the other one explained the bioequivalence between brand name and generic drugs (n = 35). The control video informed participants about the epidemiology and etiology of headaches (n = 34). After watching the video, participants treated their next two consecutive episodes of headache with a brand name and a generic analgesic in randomized order.Main outcome measuresSelf-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects.ResultsLinear mixed models showed that both interventional videos improved participants’ understanding of generic medicines. The generic drug approval process video enhanced the perceived effectiveness, safety and quality of generic drugs. The bioequivalence video positively influenced the preference for generic drugs. The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.ConclusionsInformation about both, approving a switch from brand name medicines to generic counterparts and bioequivalence, can be important and should be addressed in future educational interventions. 相似文献
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目的:按照药物临床安全性和警戒性的要求,对生物仿制药的生物利用度、临床疗效安全性进行评价,以制订生物仿制药警戒计划。方法:对我国生物仿制药在前期研究、临床试验、生产等过程存在的问题进行分析。结果与结论:生物仿制药品相似但不相同,生物制剂生产过程复杂,容易出现变异,有必要进行临床安全性评价。国家各卫生医疗机构部门应高度关注,加强药品的自检、抽检、监督管理,在生物仿制药使用过程中发现问题,提高我国生物仿制药的临床安全用药水平。 相似文献