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Biosimilars: current status and future directions.

机译：生物仿制药：现状和未来方向。

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摘要

IMPORTANCE OF THE FIELD: Expiration of patents covering biopharmaceuticals, has provided opportunities for pharmaceutical companies to develop, produce and market biosimilars or follow-on biologicals. However, there have been concerns over the degree of similarity of these complex drugs in addition to the hope that their introduction may lower the cost of such expensive medicinal products. AREAS COVERED IN THIS REVIEW: The introduction/manufacturing considerations, immunogenicity and regulatory approaches to biosimilars around the world. In addition, arguments and techniques employed by pharmaceutical companies to advance or discredit biosimilar drugs will be outlined. Issues with post-marketing surveillance programmes and their limitations are described. WHAT THE READER WILL GAIN: This evaluation outlines the controversial issues associated with introduction of biosimilar medicines across a range of pharmacological indications. Also the differences between regulatory approved medicines and biopharmaceutical products not subjected to regulatory approval ('B-NSRA') are highlighted. The review is limited by the rapid changes in regulatory approval and licencing of biosimilars. TAKE HOME MESSAGE: Hopefully biosimilar medicines will allow more widespread availability of expensive biopharmaceutical products. Clinicians need to be wary of non-transparent promotion of innovator/biosimilar products.
机译：领域的重要性：涵盖生物制药的专利到期为制药公司提供了开发，生产和销售生物仿制药或后续生物制剂的机会。但是，除了希望引入这些复合药物可以降低这种昂贵药物的成本外，还对这些复杂药物的相似程度存在担忧。此次审查涉及的领域：全球生物仿制药的引进/生产考虑，免疫原性和监管方法。此外，还将概述制药公司用来推进或抹杀生物仿制药的争论和技术。描述了上市后监督计划的问题及其局限性。读者的收获：这项评估概述了与跨药理适应症的生物仿制药的引入有关的有争议的问题。还强调了监管批准的药品与未经监管批准的生物制药产品（“ B-NSRA”）之间的差异。审查受到法规批准和生物仿制药许可快速变化的限制。寄语：希望生物仿制药将允许更广泛地获得昂贵的生物制药产品。临床医生需要警惕非透明地推广创新者/生物仿制药产品。

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