CAJ | 학술논문

一批原创生物治疗药品的专利保护即将到期.预计其仿制品在不久将来会竞相上市.生物制品是利用高端生物技术研制的大分子蛋白质,其分子结构及生产流程均较经典化学药品复杂得多.因此生物仿制品在结构、作用及安全性等方面与其原创品只相似而不相同,故不能替代原创品.临床应用时应对其质量及安全性,尤其是免疫原性等问题有充分了解同时药监部门应对生物仿制品的研发,生产及上市的报批以及上市后不良反应监察等环节严格监管.
일비원창생물치료약품적전리보호즉장도기.예계기방제품재불구장래회경상상시.생물제품시이용고단생물기술연제적대분자단백질,기분자결구급생산류정균교경전화학약품복잡득다.인차생물방제품재결구、작용급안전성등방면여기원창품지상사이불상동,고불능체대원창품.림상응용시응대기질량급안전성,우기시면역원성등문제유충분료해동시약감부문응대생물방제품적연발,생산급상시적보비이급상시후불량반응감찰등배절엄격감관.
A number of biosimilars will be soon marketing due to the expiration of patent protection of their originators.Unlike classical chemical drugs,biotherapeutics are proteins with large and complex molecules produced by biological high-tech with sophisticated manufactural procedures.This leads to the difficulties of the copy of biosimilars from their originators,and the almost inevitable distinctions between the two products.Thus biosimilars are only similar but not identical to their reference drugs in terms of stracture,action,and safety.It is important for physicians to understand these differences before using biosimilars.Optimal management by a national regulatory authority with rigorous standards is very important in all aspects of authorization of the development,production,marketing,and postmarketing surveillances for biosimilars.