Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods

评估创新方法批准的仿制药的临床等效性

• 批准号: 8660859
• 负责人: AARON SETH KESSELHEIM
• 金额: $ 24.77万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-15 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8660859
• 关键词: Assessing; Clinical; Equivalence; Generic; Drugs

Summary/Abstract Generic drugs make up about 80% of all drug prescribing, and less costly generic drugs promote medication adherence among patients and reduce wasteful health care spending. The success of the generic drug industry relates to the interchangeability of brand name and generic drugs, which in turn relies on the FDA's certification of generic drugs as bioequivalent. In recent years, the FDA has taken a number of different innovative approaches to determining bioequivalence due to unique characteristics of particular drugs. Since these cases have raised controversy, the goal of this project is to use different empirical approaches to study the clinical implications of the FDA's bioequivalence determination in 6 specific circumstances: the approval of generic venlafaxine ER, calcitonin salmon nasal spray, enoxaparin, acarbose, vancomycin capsules, and sodium ferric gluconate. First, we will conduct a national survey of patients to determine their opinions about generic drug safety and effectiveness, attitudes about bioequivalent generic drugs approved via innovative mechanisms, and knowledge about controversies relating to the six specific model drugs at issue in this application. We will use a base population of nearly 125,000 patients and survey those who have filled prescriptions for one of the 6 drugs of interest or other drugs indicated for the same conditions. Second, we will conduct a national survey of physicians to assess the same outcomes. For this survey, we will identify a random national sample of board certified internists, and use online survey tools previously employed in surveys of this population. Third, using large national claims databases, we will identify "switchback" rates related to the 6 generic drugs (episodes of patients receiving generic versions of the drug and then switching back to the brand name formulations in subsequent prescriptions), and determine whether these switchback rates differ significantly from switchbacks for other related but non-controversial generic drugs. To determine the reliability of switchback studies, we will compare our results to alternative analyses of generic and brand-name drug use that may better account for confounding. Finally, we will conduct systematic reviews and meta-analyses of studies of the 6 generic drugs to determine if any evidence exists in the literature of differences in their safety or effectiveness compared with the brand-name versions. These data will help the FDA assess the success of the innovative regulatory approaches used for these 6 generic drugs and evaluate whether similar pathways may be used for bioequivalence determinations related to future drugs.

总结/摘要 仿制药占所有药物处方的80%左右， 促进病人坚持服药，减少浪费性的保健开支。的 非专利药品行业的成功与品牌名称和非专利药品的可重复性有关。 这反过来又依赖于FDA对仿制药的生物等效性认证。近几 多年来，FDA采取了许多不同的创新方法来确定 生物等效性是由于特定药物的独特特性。由于这些案件已经引起了 争议，该项目的目标是使用不同的经验方法来研究临床 FDA在6种特定情况下的生物等效性测定的影响：批准 通用文拉法辛ER，鲑鱼降钙素鼻喷雾剂，依诺肝素，阿卡波糖，万古霉素 胶囊和葡萄糖酸铁钠。首先，我们将对患者进行全国性调查， 确定他们对仿制药安全性和有效性的看法， 通过创新机制批准的生物等效仿制药，以及 与本申请中有争议的六种特定模型药物有关的争议。我们将使用一个 近125，000名患者的基本人群，并调查那些已填写处方的患者， 6种目标药物之一或适用于相同病症的其他药物。二是 对医生进行全国性调查，以评估相同的结果。在这次调查中，我们将 确定一个委员会认证的内科医生的随机国家样本，并使用在线调查工具 以前在调查这一人群时使用过。第三，利用大型国家索赔数据库， 我们将确定与6种仿制药相关的“转向”率（患者接受 仿制药，然后切换回品牌配方， 随后的处方），并确定这些转向率是否有显著差异 从其他相关但无争议的仿制药转向。确定 转向研究的可靠性，我们将比较我们的结果，通用的替代分析 和使用名牌药物可能更好地解释混淆。最后，我们将进行 对6种仿制药的研究进行系统综述和荟萃分析，以确定是否存在 文献中存在证据表明，与 品牌版本。这些数据将有助于FDA评估创新的成功 用于这6种仿制药的监管方法，并评估是否存在类似的途径 可用于与未来药物相关的生物等效性测定。

项目成果

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

修改美国仿制药批准的监管途径及其结果的系统审查。

• DOI: 10.1007/s40265-015-0382-1
• 发表时间: 2015
• 期刊: Drugs
• 影响因子: 11.5
• 作者: Kesselheim,AaronS;Polinski,JenniferM;Fulchino,LisaA;Isaman,DanielleL;Gagne,JoshuaJ
• 通讯作者: Gagne,JoshuaJ

Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence.

与使用特定产品的治疗等效性确定批准的仿制药相关的转换。

• DOI: 10.1002/pds.4009
• 发表时间: 2016
• 期刊: Pharmacoepidemiology and drug safety
• 影响因子: 2.6
• 作者: Gagne,JoshuaJ;Polinski,JenniferM;Jiang,Wenlei;Dutcher,SarahK;Xie,Jing;Lii,Joyce;Fulchino,LisaA;Kesselheim,AaronS
• 通讯作者: Kesselheim,AaronS