摘 要
生物类似药的研发评价与临床应用是当前医药领域的重要研究方向。随着原研生物药专利到期，生物类似药的研发成为降低医疗成本、提高患者用药可及性的关键途径。本研究旨在系统评估生物类似药的研发流程、质量控制标准及其临床应用安全性与有效性。通过对国内外已上市生物类似药的全面分析，结合细胞水平、动物实验和临床试验三个层面的研究方法，重点考察了生物类似药在结构相似性、生物学活性、免疫原性等方面的特性。研究结果表明，严格遵循国际通行的质量对比研究指南进行研发的生物类似药，在药代动力学特征、药效学表现以及长期安全性方面均与原研药具有高度一致性。本研究创新性地提出了基于全生命周期管理理念的质量评价体系，并建立了涵盖生产过程控制、成品质量检测及上市后监测的一体化评价模式，为生物类似药的规范化研发提供了科学依据。该研究成果不仅完善了生物类似药的研发评价理论框架，还为临床合理使用生物类似药提供了重要参考，对推动我国生物医药产业健康发展具有重要意义。
关键词：生物类似药；研发评价；临床应用；质量控制；全生命周期管理
Abstract
The development, evaluation, and clinical application of biosimilars represent a critical research direction in the pharmaceutical field. As patents for originator biologics expire, the development of biosimilars has become a key approach to reducing healthcare costs and improving patient access to medications. This study aims to systematically assess the development process, quality control standards, and clinical safety and efficacy of biosimilars. Through comprehensive analysis of biosimilars approved both domestically and internationally, combined with research methods at the cellular level, animal experimentation, and clinical trials, this study focuses on evaluating characteristics of biosimilars such as structural similarity, biological activity, and immunogenicity. The results demonstrate that biosimilars developed in strict adherence to internationally accepted quality comparability guidelines exhibit high consistency with originator drugs in pharmacokinetic profiles, pharmacodynamic performance, and long-term safety. Innovatively, this study proposes a quality evaluation system based on the concept of lifecycle management and establishes an integrated evaluation model encompassing process control during production, finished product quality testing, and post-market surveillance. This provides scientific evidence for the standardized development of biosimilars. The findings not only enhance the theoretical fr amework for the evaluation of biosimilar development but also offer important references for the rational clinical use of biosimilars, significantly contributing to the healthy development of China's biopharmaceutical industry.
Keywords：Biological Similar Drugs；Research And Development Evaluation；Clinical Application；Quality Control；Whole Life Cycle Management
目 录
摘 要 I
Abstract II
引 言 1
第一章 生物类似药的研发基础 2
1.1 生物类似药的定义与特性 2
1.2 研发的基本流程与挑战 2
1.3 关键技术平台的应用 3
第二章 生物类似药的质量评价 5
2.1 结构相似性评估方法 5
2.2 功能活性的比较分析 5
2.3 质量控制标准的确立 6
第三章 生物类似药的临床试验设计 7
3.1 临床前研究的重要性 7
3.2 临床试验的设计原则 7
3.3 安全性和有效性评估 8
第四章 生物类似药的临床应用前景 10
4.1 医疗体系中的定位 10
4.2 经济效益与社会影响 10
4.3 未来发展方向展望 11
结 论 12
参考文献 13
致 谢 14
