PDF(Pubmed)
Abstract：
Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine. Whereas biosimilars are subject to a dedicated regulatory framework in the EU, synthetically produced follow-on products are not eligible for assessment through this pathway, requiring approval via the traditional generic pathway under Article 10 (1), or via the hybrid pathway under Article 10 (3). This review presents an overview of recent developments in the field of synthetic peptides referencing biological originators in the EU. The use of different regulatory procedures can have potential implications for regulatory assessments, clinical practice and pharmacovigilance. As more complex synthetic products referencing recombinant originator products are expected in the coming years, this study promotes more transparency as well as global alignment about regulatory procedures for chemically synthesised products referencing biological originator products to ensure approval of safe and high-quality generics.
摘要：
合成药物制造的最新进展为欧洲监管体系带来了新的动力，以生物起源产品为参考药物的化学合成多肽产品。尽管生物仿制药在欧盟受到专门的监管框架的约束，合成生产的后续产品不符合通过该途径进行评估的条件，需要通过第10(1)条规定的传统通用途径获得批准，或通过第10(3)条规定的杂交途径。这篇综述概述了参考欧盟生物起源的合成肽领域的最新进展。使用不同的监管程序可能会对监管评估产生潜在影响，临床实践和药物警戒。随着未来几年预计将出现更复杂的合成产品，这些产品将参考重组鼻祖产品，这项研究促进了化学合成产品引用生物起源产品的监管程序的透明度和全球一致性，以确保安全和高质量的仿制药的批准。
