Prescrire Int. 2015 Mar;24(158):80-1, 83.
"Biosimilar" drug regulatory status, created in 2004 for copies of "biological" drugs, is far more onerous than "generic" drug status. The possibility of substituting a cheaper copy for an originator drug once its market monopoly has expired has major implications for the efficient management of healthcare expenditure.The context surrounding the creation of the concept of "biosimilarity" was one of originator pharmaceutical companies trying to defend their turf by preventing copies of biotechnology-derived drugs from acquiring the status of generics. While generic drugs are authorised on the basis of an abridged application, companies that wish to market a copy of a biotechnology-derived drug must provide the results of specific preclinical tests and clinical trials.The reasons put forward are, in particular, technical difficulties in establishing the similarity of complex biological substances. In May 2013, the European Medicines Agency (EMA) released for public consultation a draft revision of its guidelines on the evaluations required to obtain marketing authorisation for copies of "biological" drugs.This EMA proposal would relax a number of requirements that are of little value to patients and delay the market introduction of these copies. In late 2014 and early 2015, the EMA adopted the final version of these guidelines. The response of the Medicines in Europe Forum and the International Society of Drug Bulletins (ISDB) to this consultation provided an opportunity to review the current situation regarding "biosimilars", ten years after this regulatory status was created. These two international networks supported the EMA's pragmatic proposals to no longer require that clinical trials be routinely conducted before "biosimilar" drugs can be authorised. This response also provided an opportunity to stress that unless a difference in efficacy or adverse effects is demonstrated, assigning a different international nonproprietary name (INN) from that of the originator drug would lead to a profusion of names for the same drug and cause unnecessary confusion for healthcare professionals and patients.
“生物类似药”的药品监管状况于2004年针对“生物”药品的仿制品设立，比“仿制药”的监管状况要严格得多。一旦原研药的市场垄断期结束，用更便宜的仿制品替代原研药的可能性对医疗保健支出的有效管理具有重大影响。“生物相似性”概念产生的背景是，原研制药公司试图通过阻止生物技术衍生药物的仿制品获得仿制药地位来捍卫自己的地盘。虽然仿制药是根据简化申请获得批准的，但希望销售生物技术衍生药物仿制品的公司必须提供特定临床前试验和临床试验的结果。提出的理由尤其包括确定复杂生物物质相似性方面的技术困难。2013年5月，欧洲药品管理局（EMA）发布了其关于“生物”药品仿制品获得上市许可所需评估指南的修订草案，以供公众咨询。EMA的这项提议将放宽一些对患者价值不大的要求，并推迟这些仿制品的市场推出。2014年末和2015年初，EMA通过了这些指南的最终版本。欧洲药品论坛和国际药品公报协会（ISDB）对此次咨询的回应提供了一个机会，在这种监管状况设立十年后审视“生物类似药”的现状。这两个国际网络支持EMA的务实提议，即不再要求在“生物类似药”获得批准之前常规进行临床试验。这一回应还提供了一个机会来强调，除非证明疗效或不良反应存在差异，否则给仿制药赋予与原研药不同的国际非专利名称（INN）会导致同一药物出现大量名称，并给医疗保健专业人员和患者造成不必要的混乱。
