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首页> 外文期刊>International Journal of Research in Medical Sciences >Biologics and biosimilars: role in modern pharmacotherapy and importance of pharmacovigilance
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Biologics and biosimilars: role in modern pharmacotherapy and importance of pharmacovigilance

机译：生物制剂和生物仿制药：在现代药物治疗中的作用和药物警戒的重要性

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Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. Examples are therapeutic hormones, vaccines, monoclonal antibodies etc. Biologicals are beneficial in the management of several health conditions which were once upon a time difficult to manage like cancer, multiple sclerosis, Alzheimer's disease, rheumatoid arthritis, diabetes etc. Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biosimilars are not the exact replicas of originator biologic and are therefore not generics. Biosimilars for their approval are not required to undergo intense clinical trials as innovator biologic but are required to produce data that demonstrates its similarity to an original biologic in terms of clinical efficacy and safety. However, manufactures of both the biologics and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application. Marketing authorization for biosimilars was for the first time framed by EMA along with the guidelines for developing them. As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer. Regulations are implemented to improve identification and traceability of biologics. Automatic substitution should not be permitted for biologicals.
机译：生物制剂是高度敏感的大分子，结构复杂，难以表征和繁殖，来源于活细胞。用于治疗，诊断或预防疾病。例子是治疗性激素，疫苗，单克隆抗体等。生物制剂有益于治疗曾经难以控制的多种健康状况，例如癌症，多发性硬化症，阿尔茨海默氏病，类风湿性关节炎，糖尿病等。生物仿制药是与创新生物制剂相似，但结构不同，但在临床上无显着差异。生物仿制药不是原始生物仿制品的精确复制品，因此不是仿制药。批准使用的生物仿制药不需要作为创新生物制剂进行严格的临床试验，而是需要提供证明其在临床功效和安全性方面与原始生物仿制药相似的数据。但是，生物制剂和生物仿制药的制造商都必须提交药物警戒和风险管理计划，作为其应用的一部分。 EMA首次将生物仿制药的销售授权与开发指导方针一起制定。由于生物制品和生物仿制药是衍生蛋白质，因此它们具有免疫原性潜力和不良事件风险，因此请谨慎使用。需要进行药物警戒以确保迅速检测，报告不良事件并归因于正确的产品和制造商。实施法规以改善生物制剂的识别和可追溯性。不允许自动替代生物制剂。

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