García-Arieta Alfredo, Blázquez Antonio
Division de Farmacologia y Evaluacion Clinica, Subdirección General de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, C/ Campezo 1. Edificio 8, Planta 2 Oeste, E-28022 Madrid, Spain.
Curr Drug Discov Technol. 2012 Jun 1;9(2):137-42. doi: 10.2174/1570163811209020137.
The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of "similar biological medicinal product" that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union. This different legal basis determines directly the technical requirements to obtain a marketing authorisation. Therefore, the chemical/biological, non-clinical and clinical requirements to demonstrate therapeutic equivalence are different in these two Regulatory Authorities, FDA and EMA. Consequently, the possible conditions of use are different. In the United States the products approved as generics by the FDA are considered interchangeable to the Reference Listed Drug. In contrast, the EMA legislation only deals with the approvability or prescribability of the medicines and it is a national / regional decision of the member States to consider these biosimilar products as interchangeable or not.
本文旨在探讨分别在美国和欧盟上市的低分子量肝素仿制药和生物类似药的法律层面、技术要求及可能的使用条件。为此，将欧盟药品法规于2003年提出的“相似生物药产品”概念与美国的仿制药概念以及欧盟的仿制药概念进行了比较。这种不同的法律基础直接决定了获得上市许可的技术要求。因此，美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）这两个监管机构在证明治疗等效性方面的化学/生物学、非临床和临床要求各不相同。相应地，可能的使用条件也有所不同。在美国，FDA批准为仿制药的产品被认为可与参比上市药品互换。相比之下，EMA的法规仅涉及药品的可批准性或可处方性，成员国需自行决定是否将这些生物类似药产品视为可互换药品。
