• 【评论:在印度视网膜疾病中使用生物仿制药:挑战和关注。】 复制标题 收藏 收藏
    DOI:10.4103/ijo.IJO_39_21 复制DOI
    作者列表:Kumar A,Agarwal D,Kumar A
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【在葡萄牙一家肿瘤医院对利妥昔单抗和曲妥珠单抗生物仿制药进行现实世界的强化安全监控。】 复制标题 收藏 收藏
    DOI:10.1177/1078155220957079 复制DOI
    作者列表:Mendes D,Abrantes J,Rigueiro G,Pais AF,Penedones A,Alves C,Batel-Marques F
    BACKGROUND & AIMS: PURPOSE:The aim of this study was to assess the safety profiles of two biosimilar medicines (rituximab and trastuzumab) in the treatment of cancer patients within a Portuguese oncology hospital. METHODS:This hospital-based prospective observational study followed a cohort event monitoring approach focused on signalling suspected adverse drug reactions (ADRs). Patients undergoing treatment with rituximab biosimilar CT-P10 (Truxima®) or trastuzumab biosimilar CT-P6 (Herzuma®) were recruited over an 11-month and a 6-month period, respectively. Clinicians identified eligible patients and used paper-based forms to report all ADRs associated with biosimilar medicines. ADR case reports were assessed for seriousness, expectedness and causality in the Pharmacovigilance Unit of Coimbra. RESULTS:Ninety-four patients received biosimilar medicines (rituximab, n = 35; trastuzumab, n = 59). Of those, 4 patients (11.4%) experienced 16 ADRs with rituximab and 1 patient (1.7%) experienced 5 ADRs with trastuzumab. All case reports contained serious and expected ADRs that were at least probably related with biosimilar medicines under study. Based on the MedDRA PT coding, the most reported ADR for rituximab CT-P10 was chest discomfort (n = 4; 19.1%), followed by odynophagia (n = 2; 9.5%). Trastuzumab CT-P6 was associated with back pain, headache, pain in extremity, tachypnoea and tremor (each, n = 1; 4.8%). CONCLUSION:The results of this study suggest that using biosimilar rituximab and biosimilar trastuzumab to treat cancer patients in the real-world clinical setting is associated with acceptable safety profiles. No new safety problems were identified.
    背景与目标: 目的:本研究的目的是评估两种生物仿制药(利妥昔单抗和曲妥珠单抗)在葡萄牙肿瘤医院内治疗癌症患者的安全性。
    方法:这项基于医院的前瞻性观察性研究采用了队列事件监测方法,重点关注可疑药物不良反应(ADR)的信号传递。分别招募接受利妥昔单抗生物仿制药CT-P10(Truxima®)或曲妥珠单抗生物仿制药CT-P6(Herzuma®)治疗的患者,疗程分别为11个月和6个月。临床医生确定了合格的患者,并使用纸质表格报告了与生物仿制药相关的所有ADR。在科英布拉药物警戒科评估了ADR病例报告的严重性,预期性和因果关系。
    结果:94例患者接受了生物仿制药(利妥昔单抗,n = 35;曲妥珠单抗,n = 59)。在这些患者中,有4名患者(11.4%)接受了16例利妥昔单抗的ADR治疗,有1名患者(1.7%)经历了5种曲妥珠单抗的ADR。所有病例报告均包含严重的和预期的ADR,至少与所研究的生物仿制药有关。根据MedDRA PT编码,报告最多的利妥昔单抗CT-P10的ADR为胸部不适(n = 4,占19.1%),其次是咽痛(n == 2,占9.5%)。曲妥珠单抗CT-P6与背痛,头痛,四肢疼痛,呼吸困难和震颤有关(每例,n = 1; 4.8%)。
    结论:这项研究的结果表明,在现实世界的临床环境中使用生物仿制药利妥昔单抗和生物仿制药曲妥珠单抗治疗癌症患者具有可接受的安全性。没有发现新的安全问题。
  • 【生物仿制药在炎性肠疾病的治疗中。】 复制标题 收藏 收藏
    DOI:10.1097/MEG.0000000000000098 复制DOI
    作者列表:Hlavaty T,Letkovsky J
    BACKGROUND & AIMS: :A biosimilar is a copy of an approved biological medicine whose patent protections have expired. Biosimilars of antibodies to tumour necrosis factor α (TNFα) are becoming important in the treatment of inflammatory bowel diseases (IBD). The first one introduced commercially is an infliximab biosimilar. The aim of this study was to provide an overview of anti-TNFα biosimilars. The literature on biosimilars of monoclonal anti-TNFα antibodies was reviewed, including their manufacture and approval pathways, concerns about efficacy, safety, immunogenicity, extrapolation, switching and labelling. Previous experience with biosimilars of epoetin and other growth factors was also reviewed. The infliximab biosimilar CT-P13 was the first biosimilar monoclonal antibody registered for the treatment of IBD. The major advantage of biosimilars is the reduced cost of therapy. Concerns have arisen, however, about the efficacy and safety of CT-P13 in IBD, the extrapolation of results from rheumatologic trials to IBD and the free interchangeability of CT-P13 with infliximab. Experience with simple peptide biosimilars, such as epoetins and growth factors, has generally been positive, with these biosimilars having similar efficacy and safety as the original products, although immunogenicity remains a major concern. Upcoming postregistration studies will address concerns on biosimilars in IBD, including their efficacy, safety, immunogenicity, switching and interchangeability. Biosimilars active against the same epitopes, but with improved pharmacokinetic properties that enhance their efficacy and/or safety, may be the next stage in the development of biosimilars. Anti-TNFα biosimilars represent promising new treatment options for patients with IBD. However, data on their efficacy and safety in IBD are needed.
    背景与目标: :生物仿制药是专利保护已过期的已批准生物药品的副本。肿瘤坏死因子α(TNFα)抗体的生物仿制药在治疗炎症性肠病(IBD)中变得越来越重要。商业上第一个引入的是英夫利昔单抗生物仿制药。这项研究的目的是提供抗TNFα生物仿制药的概述。综述了有关单克隆抗TNFα抗体生物仿制药的文献,包括其制备和批准途径,对功效,安全性,免疫原性,外推,转换和标记的关注。还回顾了以往使用依泊汀和其他生长因子的生物仿制药的经验。英夫利昔单抗生物仿制药CT-P13是第一个注册用于治疗IBD的生物仿制药单克隆抗体。生物仿制药的主要优点是降低了治疗成本。然而,有关CT-P13在IBD中的功效和安全性,风湿病试验结果向IBD的推断以及CT-P13与英夫利昔单抗的自由互换性等问题引起了人们的关注。简单的肽类生物类似物(如表蛋白和生长因子)的经验通常是积极的,尽管免疫原性仍然是主要关注的问题,但这些生物类似物具有与原始产品相似的功效和安全性。即将进行的注册后研究将解决对IBD中生物仿制药的关注,包括其功效,安全性,免疫原性,转换和互换性。生物仿制药对相同的表位具有活性,但具有改善的药代动力学特性,可增强其功效和/或安全性,可能是生物仿制药开发的下一阶段。抗TNFα生物仿制药代表了IBD患者的有希望的新治疗选择。但是,需要有关其在IBD中的疗效和安全性的数据。
  • 【展望未来并从最近的历史中吸取教训:利益相关者对癌症中生物仿制药的看法不断变化。】 复制标题 收藏 收藏
    DOI:10.2217/fon-2017-0154 复制DOI
    作者列表:Kim WS,Ogura M,Kwon HC,Choi D
    BACKGROUND & AIMS: :As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic. We discuss these considerations and refer to recent experiences with CT-P13, a biosimilar of the TNF inhibitor infliximab used to treat rheumatoid arthritis and other inflammatory disorders.
    背景与目标: :随着许多生物抗癌药的专利到期,预计生物仿制药的使用将显着增长,这将提供一个机会来应对不断上升的治疗费用并增加患者获得生物疗法的机会。与每种参考产品相比,涉及许多非临床和临床比较研究的监管批准的获得,只是实现生物仿制药潜在收益的几个障碍之一。如果要在临床上接受并使用生物仿制药,了解不同利益相关者的当前看法和信息需求非常重要。我们讨论这些考虑因素,并参考CT-P13的最新经验,CT-P13是用于治疗类风湿性关节炎和其他炎症性疾病的TNF抑制剂英夫利昔单抗的生物仿制药。
  • 5 Implications of biosimilars for the future. 复制标题 收藏 收藏

    【生物仿制药对未来的影响。】 复制标题 收藏 收藏
    DOI:10.2146/ajhp080212 复制DOI
    作者列表:Johnson PE
    BACKGROUND & AIMS: PURPOSE:Historical perspective on the use of biotechnology for drug product development, terminology used for biotechnology drug products, potential benefits of biotechnology, applications of biotechnology to drug product development, pharmacy considerations in the use of biopharmaceuticals, and the classification of biotechnology products by the Food and Drug Administration (FDA) are discussed. SUMMARY:Applications of biotechnology to medicine have a long history, and the pace of new applications has accelerated in recent decades. Various terms, including biosimilars, follow-on biologics, and follow-on proteins, have been used to refer to biotechnology products that are highly similar to the reference product, notwithstanding minor differences. New approaches to the production of drug products have been made feasible through biotechnology, facilitating the prevention, cure, and treatment of diseases. Recombinant DNA technology, monoclonal antibodies, and gene therapy are among the applications of biotechnology processes to drug development. Storage, handling, preparation, and administration are among the pharmacy considerations in the use of biopharmaceuticals. The FDA has not defined or developed a pathway for establishing therapeutic equivalence of biosimilar and innovator products. Payers may attempt to make decisions about therapeutic equivalence in order to reduce costs. CONCLUSION:Considerable confusion surrounds biosimilars. Pharmacists can help resolve the confusion by explaining to lawmakers and health-system decision-makers the terminology and science of biotechnology processes and the implications for use of biotechnology products in the future.
    背景与目标: 目的:关于使用生物技术进行药品开发的历史观点,用于生物技术药品的术语,生物技术的潜在利益,生物技术在药品开发中的应用,使用生物药品的药学注意事项以及生物技术产品的分类讨论了食品和药物管理局(FDA)。
    摘要:生物技术在医学上的应用历史悠久,近几十年来,新应用的发展步伐加快了。尽管有微小差异,但包括生物仿制药,后续生物制剂和后续蛋白质在内的各种术语已用于指代与参考产品高度相似的生物技术产品。通过生物技术使药物生产的新方法变得可行,从而促进了疾病的预防,治疗和治疗。重组DNA技术,单克隆抗体和基因疗法是生物技术过程在药物开发中的应用。储存,处理,制备和给药是生物药物使用中的药学考虑事项。 FDA尚未定义或开发出建立生物仿制药和创新药物等效性的途径。付款人可以尝试就治疗等效性做出决定,以降低成本。
    结论:生物仿制药存在相当大的困惑。药剂师可以通过向立法者和卫生系统决策者解释生物技术过程的术语和科学以及未来使用生物技术产品的含义,来帮助解决这种困惑。
  • 6 The protein science of biosimilars. 复制标题 收藏 收藏

    【生物仿制药的蛋白质科学。】 复制标题 收藏 收藏
    DOI:10.1093/ndt/gfl474 复制DOI
    作者列表:Kuhlmann M,Covic A
    BACKGROUND & AIMS: :A sea change is occurring in the off-patent drug manufacturing industry with a first wave of biotechnologically derived products reaching the end of their patent lives. However, recombinant proteins are in a different league from their chemical predecessors in terms of molecular complexity. Small differences in manufacturing processes can affect the efficacy and safety of the recombinant proteins in a manner which is not always measurable using analytical or in vitro techniques. Thus, comparable clinical profiles do not automatically follow from physicochemical likeness and can only be demonstrated through clinical studies. It is essential for patient safety that both innovator and biosimilar manufacturers ensure consistency in their production, by performing rigorous purity and activity profiling between batches, and implement tailored pharmacovigilance plans.
    背景与目标: :在非专利药物制造行业中发生了巨变,第一波生物技术衍生产品的专利生命期即将结束。但是,就分子复杂性而言,重组蛋白与其化学前身处于不同的联盟。制造过程中的细微差异可能会以无法始终使用分析或体外技术进行测量的方式影响重组蛋白的功效和安全性。因此,可比较的临床特征不会自动从理化相似性中得出,而只能通过临床研究来证明。对于患者安全而言,创新者和生物仿制药制造商都必须执行严格的纯度和批次间活性分析,并实施量身定制的药物警戒计划,以确保其生产的一致性,这对患者而言至关重要。
  • 【有关生物仿制药市场准入的卫生经济指南。】 复制标题 收藏 收藏
    DOI:10.1080/14712598.2021.1849132 复制DOI
    作者列表:Simoens S,Vulto AG
    BACKGROUND & AIMS: :Introduction: Little is known about market access to biosimilars from a health economic perspective, except for studies that compute the budget impact of biosimilar use. Areas covered: This comprehensive health economic guide to the market access of biosimilars focuses on the role of biosimilars in pharmaceutical innovation and competition, the objective of biopharmaceutical policy, the budget impact of biosimilars, and the cost-effectiveness of biologic therapy in the presence of biosimilars. Expert opinion: We argue that the objective of biopharmaceutical policy in a health system should be to create a competitive and sustainable market for off-patent reference biologics, biosimilars, and next-generation biologics that makes biologic therapy available to patients at the lowest cost. Market access of biosimilars can contribute to this objective as a result of the lower price of biosimilars and price competition with alternative therapies. The resulting improvement in the cost-effectiveness of biologic therapy needs to be accounted for by revisiting reimbursement decisions and conditions. When examining the cost-effectiveness of biologic therapy following patent expiry, stakeholders need to consider residual uncertainties at the time of biosimilar marketing authorization, the nocebo effect, market entry of a second-generation reference biologic with a different administration form than the biosimilar, and value-added services.
    背景与目标: :简介:从健康经济学的角度对生物仿制药的市场准入知之甚少,但有关计算生物仿制药使用的预算影响的研究除外。涵盖的领域:这份有关生物仿制药市场准入的全面卫生经济指南,重点关注生物仿制药在药物创新和竞争中的作用,生物制药政策的目标,生物仿制药的预算影响以及存在生物仿制药的成本效益。生物仿制药。专家意见:我们认为,卫生系统中生物药物政策的目标应该是为专利非专利参考生物制剂,生物仿制药和下一代生物制剂创建一个竞争性和可持续性市场,以最低的成本为患者提供生物治疗。由于生物仿制药的较低价格以及与替代疗法的价格竞争,生物仿制药的市场准入可有助于实现这一目标。需要通过重新考虑报销决定和条件来说明生物治疗成本效益的最终改善。在检查专利到期后生物疗法的成本效益时,利益相关者需要考虑生物仿制药上市授权时的残留不确定性,nocebo效应,具有与生物仿制药不同的管理形式的第二代参考生物制剂的市场准入,以及增值服务。
  • 【两种pegfilgrastim生物仿制药的功效和安全性:Tripegfilgrastim和pegteograstim。】 复制标题 收藏 收藏
    DOI:10.1002/cam4.3261 复制DOI
    作者列表:Kang KW,Lee BH,Jeon MJ,Yu ES,Kim DS,Lee SR,Sung HJ,Choi CW,Park Y,Kim BS
    BACKGROUND & AIMS: :Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte-colony stimulating factor (G-CSF) analog filgrastim with those of the reference pegfilgrastim. We retrospectively analyzed data from patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who were treated with first-line R-CHOP chemotherapy and received pegylated G-CSF for primary prophylaxis. The following pegylated G-CSFs were analyzed in this study: reference pegfilgrastim (Neulasta® ) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg® ). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R-CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P < .001). The number of patients with at least one episode of febrile neutropenia was also lowest in the reference cohort (pegfilgrastim: 67 of 193 patients, 34.7%; tripegfilgrastim: 38 of 69 patients, 55.1%; pegteograstim: 16 of 34 patients, 47.1%, P = .009). There were no differences in the duration of neutropenia and febrile neutropenia or treatment outcomes (rate of complete response or relapse and survival). There were no reports of grade 3 or higher adverse events requiring discontinuation of prophylactic pegylated G-CSF in any group. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored.
    背景与目标: :我们的目的是比较两种新近开发的pegfilgrastim生物仿制药的功效和安全性,pegfilgrastim是一种聚乙二醇化形式的重组人粒细胞集落刺激因子(G-CSF)类似物非格司亭的聚乙二醇化形式,与参考pegfilgrastim的仿制药相似。我们回顾性分析了诊断为弥散性大B细胞淋巴瘤(DLBCL)的患者的数据,这些患者接受了一线R-CHOP化疗并接受了聚乙二醇化G-CSF的一级预防。在本研究中分析了以下聚乙二醇化的G-CSF:参比非格司亭(Neulasta®)及其两种生物仿制药(tripegfilgrastim;Dulastin®和pegteograstim;Neulapeg®)。总共招募了296名患者。在参考队列中,R-CHOP化疗期间发生至少1次中性粒细胞减少症的患者人数最低(pegfilgrastim:193名患者中的127名,占65.8%; tripegfilgrastim:69名患者中的64名,占92.8%; pegteograstim:34名患者中的28名,82.4%,P <.001)。在参考队列中,至少发生一次发热性中性粒细胞减少症的患者人数也最低(pegfilgrastim:193例患者中的67例,占34.7%; tripegfilgrastim:69例患者中的38例,占55.1%; pegteograstim:34例患者中的16例,占47.1%, P = .009)。中性粒细胞减少和发热性中性粒细胞减少的持续时间或治疗结果(完全缓解率或复发率和生存率)没有差异。在任何组中均没有3级或更高级别不良事件需要预防性聚乙二醇化G-CSF停药的报道。 pegfilgrastim生物仿制药在预防方面的安全性与参考pegfilgrastim相似。然而,就其功效而言,中性粒细胞减少和发热性中性粒细胞减少的发生率往往比使用培非非司亭时高。这些结果在生物仿制药研究中的临床意义应予以探讨。
  • 【美国科罗拉多州肿瘤患者中生物仿制药的知识和认识。】 复制标题 收藏 收藏
    DOI:10.2217/fon-2019-0194 复制DOI
    作者列表:Ismailov RM,Khasanova ZD,Gascon P
    BACKGROUND & AIMS: :Aim: We aimed to improve oncology patients' knowledge and awareness of biosimilars. Subsequently, we conducted an assessment of this knowledge by use of an anonymous online survey. Patients & methods: Printed materials discussing major topics related to biosimilars were developed during Phase I of our educational initiative. The brochures contained a link to the online survey. Results: A total of 79 patients responded to our survey. More than 70% of survey participants selected the correct definition of biosimilars and nearly 80% did so on questions focused on regulation, adverse reactions reporting and cost issues related to biosimilars. Conclusion: Our results indicate a good level of both knowledge and awareness of major topics concerning biosimilars among our survey participants.
    背景与目标: :目的:我们旨在提高肿瘤患者对生物仿制药的了解和认识。随后,我们通过匿名在线调查对这种知识进行了评估。患者与方法:在我们的教育计划的第一阶段中,讨论了与生物仿制药有关的主要主题的印刷材料已经开发出来。宣传册包含在线调查的链接。结果:共有79位患者对我们的调查作出了回应。超过70%的调查参与者选择了正确的生物仿制药定义,将近80%的人选择了针对法规,不良反应报告以及与生物仿制药相关的成本问题的问题。结论:我们的结果表明,我们的调查参与者对生物仿制药的主要主题具有很高的知识和意识水平。
  • 【巴西生物仿制药法规的优缺点:对巴西生物仿制药法规要求的批判性看法。】 复制标题 收藏 收藏
    DOI:10.1177/1759720X18809683 复制DOI
    作者列表:de Assis MR,Pinto V
    BACKGROUND & AIMS: :Biological products or biopharmaceuticals are medicinal products derived from living systems and manufactured by modern biotechnological methods that differ widely from the traditional synthetic drugs. Monoclonal antibodies are the most rapidly growing type of biologic. They are much larger and more complex molecules with inherent diversity; therefore, different manufacturers cannot produce identical biological products, even with the same type of host expression system and equivalent technologies. Thus, legal follow-on biologics manufactured and marketed after patent expiration are usually referred to as biosimilars. Biosimilarity is based on a comparability exercise whereby unavoidable clinical differences are evaluated and must meet equivalence or non-inferiority criteria. Biosimilars need to comply with different regulatory requirements for market authorization in different sites. There are several other related issues that need to be defined by the national authorities, such as interchangeability, labeling and prescribing information. The Brazilian health surveillance agency follows the key principles established by the World Health Organization for the assessment of biosimilarity, although does not adopt the name 'biosimilar'. However, the agency also made a compromise on a standalone application pathway that does not require the usual comparability exercise with the reference product, originating nonbiosimilar copies. Interchangeability and the use of nonproprietary names are not regulated, giving rise to pressures on physicians and conflicts of interest in the decision making on biosimilar use. The scope of this article is to present the Brazilian regulation on biosimilars, its strengths and weaknesses, and to discuss it in the face of regulations in the USA and Europe.
    背景与目标: :生物产品或生物药品是衍生自生命系统并通过现代生物技术方法制造的药品,与传统的合成药物大不相同。单克隆抗体是生物增长最快的类型。它们是更大,更复杂的分子,具有固有的多样性。因此,即使使用相同类型的宿主表达系统和等效技术,不同的制造商也无法生产相同的生物产品。因此,专利到期后生产和销售的合法后续生物制剂通常被称为生物仿制药。生物相似性基于可比性演习,在该演习中必须评估不可避免的临床差异,并且必须符合等效性或非劣效性标准。生物仿制药需要遵守不同监管要求,以在不同地点进行市场授权。国家主管部门还需要定义其他一些相关问题,例如互换性,标签和处方信息。巴西卫生监督局遵循世界卫生组织为评估生物相似性而确立的关键原则,尽管未采用“生物相似性”这一名称。但是,该机构还对独立的应用途径做出了妥协,该途径不需要与非生物仿制药的参考产品进行通常的可比性测试。互换性和非专有名称的使用不受管制,这给医师带来了压力,并在生物仿制药使用的决策中产生了利益冲突。本文的范围是介绍巴西关于生物仿制药的法规,其优缺点,并与美国和欧洲的法规进行讨论。
  • 【解决未满足的临床需求:生物仿制药在风湿病治疗中的潜力。】 复制标题 收藏 收藏
    DOI:10.1093/rheumatology/kex275 复制DOI
    作者列表:Schulze-Koops H
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【全球生物仿制药的卫生技术评估:范围界定审查。】 复制标题 收藏 收藏
    DOI:10.1186/s12961-020-00611-y 复制DOI
    作者列表:Ascef BO,Lopes ACF,de Soárez PC
    BACKGROUND & AIMS: BACKGROUND:Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices. MAIN BODY:A scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed. CONCLUSION:HTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.
    背景与目标: 背景:卫生技术评估(HTA)应该提供对技术对健康的影响以及相关的社会,经济,组织和道德问题的评估。关于生物仿制药的HTA报告可以专门评估其免疫原性,将其推导至一种或多种条件以及可互换和替代的风险。我们的目标是在HTA组织范围内完成范围界定审查,以合成有关生物仿制药的HTA报告,并绘制其扩展名,范围和方法实践。
    主体:采用了范围界定审查方法。截至2019年6月,生物仿制药HTA报告的来源是来自HTA组织网站的数据库搜索和灰色文献。生物仿制药的HTA报告被分类为完整HTA,小型HTA或快速评论。提取数据并将其记录在已校准的预定义数据表格中。我们确定了70个来自10个国家的13个HTA组织生产的16种生物制品的生物仿制药的HTA报告(2015-2018年为65.71%); 2个完整的HTA,4个小型HTA和64个快速审核符合纳入标准。几乎所有的快速评论都没有提供有关任何证据合成方法的信息,并且大约一半的快速评论都没有评估偏倚于基础研究或整体证据质量的风险。所有完整的HTA和小型HTA都针对组织,道德,社会和法律方面的考虑,而在不到一半的快速评估中对这些因素进行了评估。通常考虑一种或多种条件的免疫原性和外推法。完整的HTAs和迷你HTA大多包含转换评估和有关生物仿制药的教育方法的讨论。没有HTA报告拒绝接受所评估的生物仿制药的报销。
    结论:生物仿制药的HTA是在HTA组织的背景下出现的,并且存在的生物仿制药经常重复相同生物仿制药的报道。关于生物仿制药的大多数HTA报告都没有进行系统的文献综述或考虑经济问题。没有报告拒绝采用/偿还生物仿制药。有必要标准化开发生物仿制药HTA的最低标准,以确保更好的理解和更好的决策。
  • 【生物仿制药论坛赞扬食品药品管理局开展了新的教育计划,以促进生物仿制药的安全性和有效性。】 复制标题 收藏 收藏
    DOI:10.1093/rheumatology/kex473 复制DOI
    作者列表:
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【低分子量肝素生物仿制药:有关您的药物配方的相关背景信息。】 复制标题 收藏 收藏
    DOI:10.1111/bcp.14081 复制DOI
    作者列表:Brouwers JRBJ,Roeters van Lennep JE,Beinema MJ
    BACKGROUND & AIMS: :Biosimilars of low molecular weight heparins (LMWHs) are more alike the originator than different branded LMWHs. The latter differ largely in molecular weight, anti-FXa/anti-FIIa ratio and antithrombin binding. The Food and Drug Administration and European Medicines Agency guidelines are sufficient for the clinical use of high quality LMWHs. However, the Food and Drug Administration guideline lacks the results of a phase I clinical trial in the approval process. Most information about biosimilars is available for enoxaparin given that many biosimilars of enoxaparin have received market access. The guidelines of many International Thrombosis Societies for LMWH biosimilars are too stringent, not updated and impractical for formulary uptake discussions. This review gives background information on critical factors for the formulary uptake process of LMWHs with special attention for the use of the System of Objectified Judgment Analysis/Infomatrix model.
    背景与目标: 低分子量肝素(LMWHs)的生物仿制药比不同品牌的LMWHs更相似。后者在分子量,抗FXa /抗FIIa比率和抗凝血酶结合方面有很大不同。食品药品监督管理局和欧洲药品管理局的指南足以用于高质量LMWH的临床使用。但是,美国食品药品监督管理局的指南缺乏批准过程中第一阶段临床试验的结果。鉴于许多依诺肝素的生物仿制药已获得市场准入,因此有关依诺肝素的大多数生物仿制药信息均可用。许多国际血栓形成协会关于LMWH生物仿制药的指导方针过于严格,没有更新,对于配方吸收的讨论不切实际。这篇综述提供了有关LMWHs配方摄入过程关键因素的背景信息,并特别注意使用客观判断分析/信息矩阵模型系统。
  • 【使用微型化平台和LC-MS / MS表征药物IgG和生物仿制药。】 复制标题 收藏 收藏
    DOI:10.2174/1389201017666160401145012 复制DOI
    作者列表:Wooding KM,Peng W,Mechref Y
    BACKGROUND & AIMS: :Therapeutic monoclonal antibodies (mAbs) have made a tremendous impact in treating patients with various diseases. MAbs are designed to specifically target a cell and illicit a response from the immune system to destroy the cell. As originator mAb drug patents are coming to an end, generic pharmaceutical companies are poised to replicate and produce so-called biosimilar drugs. MAbs are significantly more complicated than small drugs to analyze and produce. The mAb proteoform and glycoform must be as similar to the original drug as possible to be a viable replacement. The mAb proteoform is well characterized but can be altered through various undesirable reactions such as deamidation. The mAb glycoform is harder to replicate as the glycan formation is a complicated templateless one; it is proving difficult for the originator companies to produce a homogenous population of mAbs from batch to batch. Severe side-effects have occurred in patients taking mAbs with immunogenic glycans, highlighting the importance of quality control mechanisms. The complex nature of mAbs requires sensitive and robust tools amenable to the highthroughput analysis required by a manufacturing setting. Miniaturized analytical platforms for complex biosimilar analysis are still in their infancy but have shown great promise for sample preparation. Capillary electrophoresis-laser induced fluorescence remains a powerful and fast technique for routine glycan analysis. Mass spectrometry is the method of choice for the analysis of mAb proteoforms and is emerging as a powerful tool for glycoform analysis.
    背景与目标: :治疗性单克隆抗体(mAbs)在治疗各种疾病的患者中产生了巨大的影响。 MAb被设计为特异性靶向细胞,并导致免疫系统的反应破坏细胞。随着原始mAb药物专利即将到期,仿制药公司已准备好复制和生产所谓的生物仿制药。与小药相比,单克隆抗体的分析和生产要复杂得多。 mAb蛋白形式和糖形式必须与原始药物尽可能相似才能成为可行的替代品。 mAb蛋白形式已得到很好的表征,但可以通过各种不希望的反应(例如脱酰胺作用)进行改变。 mAb糖型更难复制,因为聚糖的形成是一种复杂的无模板形式。事实证明,发起公司很难在批次之间生产同质的mAb群体。服用具有免疫原性聚糖的单克隆抗体的患者发生了严重的副作用,突出了质量控制机制的重要性。 mAb的复杂性质需要灵敏而强大的工具,这些工具应适合制造环境所需的高通量分析。用于复杂生物仿制药分析的小型化分析平台仍处于起步阶段,但已显示出样品制备的巨大希望。毛细管电泳激光诱导的荧光仍然是常规聚糖分析的强大而快速的技术。质谱分析法是分析mAb蛋白形式的一种选择方法,并且正在成为进行糖形分析的有力工具。

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