共查询到15条相似文献,搜索用时 406 毫秒
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美国食品药品监督管理局(FDA)于2020年2月发布了“供企业用生物类似药和可互换的生物类似药:少于已许可的参照药所有使用条件的许可证指导原则(草案)”。该指导原则主要对少于参照药适应症的生物类似药申报注册类别和说明书的内容提出了建议。介绍该指导原则的内容,期望能扩大我国对这类药物研发和监管的视野。 相似文献
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随着多个"重磅炸弹"级原研生物药的专利逐渐到期,全球生物类似药的研发呈现出蓬勃发展的态势,各个国家及地区的监管机构也逐步明确了技术指南要求,生物类似药的发展也因各国监管方式及监管理念的不同而各具特色。介绍韩国生物类似药的批准上市情况和临床在研状况,对韩国生物类似药的研究进展进行综述。 相似文献
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Sara Francescon Giulia Fornasier Paolo Baldo 《International journal of clinical pharmacy》2018,40(4):778-782
An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and biosimilar versions have now also been approved in Europe. Being complex to develop and difficult to manufacture, the biosimilar is a drug similar but not identical in physicochemical characteristics, efficacy, and safety to an original biological drug already approved in the European Union, for which marketing exclusivity rights have expired. Generally, the safety monitoring of biosimilars follows the same requirements that apply to all biologicals, even if specific pharmacovigilance measures exist and some of them are still being debated. The manufacturing process, immunogenicity, traceability, and extrapolation of indication are keywords which may impact on the achievement of additional knowledge about the safety of a biosimilar mAb. In this article, we aim to discuss elements that play a central role in the pharmacovigilance legislation of biosimilar mAbs. 相似文献
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由于生物制品的复杂性,化学仿制药物的研究方法并不完全适用于生物仿制药物。本文将就国内外对于生物仿制药注册申请的相关技术要求进行简要回顾,并从药品评价角度提出一些对于生物仿制药药学研究问题的个人观点和看法。 相似文献
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关于生物仿制药临床评价的探讨 总被引:1,自引:0,他引:1
杨焕 《中国临床药理学与治疗学》2009,14(1):5-9
我国已上市和正在申报的生物制品绝大多数都是生物仿制药(biosimilar products),关于此类药物的临床研究如何评价,目前国内尚未制定相关的指导原则和技术要求,本文期望通过借鉴国外最新相关指导原则的内容和观点,结合国情为我所用。 相似文献
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With the imminent expiry of patents on a number of biological products on the market, the development of biosimilars (or 'follow-on biologics') creates an increasing opportunity in the biotechnology industry. Although general guidelines on the quality and safety of biological products also apply to biosimilars, there is a need to address specific requirements for developing biosimilar drugs. Since it is critical to show comparability of the biosimilar products to their reference (or innovator) products, developing the appropriate bioanalytical methods to support such preclinical and clinical comparability studies is of great importance. The present work recommends the requirements for the development and validation for both pharmacokinetic and immunogenicity assays to support the biosimilar drug development. 相似文献
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Lin-Chau Chang 《Yao wu shi pin fen xi = Journal of food and drug analysis.》2019,27(3):671-678
In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of the biosimilar pathway, influenced related companies by studying their respective perspectives and strategies revealed in literatures and publicly available resources. Perspectives of companies reveal the points of concern for the biosimilar pathway, such as data requirements, patents, interchangeability, naming, and exclusivity. Innovator companies may utilize expedited programs for serious conditions, enhance patent protection, launch programs for life-cycle extension, and develop biosimilars as well. The biosimilar companies overcoming technical barriers might need to gather convincing evidence to facilitate market penetration as well as to distinguish their products from those of other biosimilar competitors. More challenges are expected for innovator companies if international harmonization takes place, which might be worth further investigation. 相似文献