摘要
在过去的30多年中，制药业发生了令人瞩目的变化，从过去主要依靠小分子活性物质（APIs）转变为依靠生物技术分子。无论是现在还是在未来的21世纪，生物技术分手都将发挥越来越重要的作用。随着获得第一代生物技术分子专利，以及在最近一次讨论上述生物相似药品的国际公开会议上所强调的那样，生物相似药和生物仿制药开发的监管草案也正在紧锣密鼓地制定过程中。
Over the past 30 years there has been a marked shift in Ithe pharmaceutical industry from the small molecule active materials （APIs）, which have been its mainstay in the past, to the biotechnologieal molecules which are playing an ever greater part in the current pipeline and the future prospects into the 21st Century. As the first generation of these molecules are coming off patent the regulatory pathway is being decided for the development of biosimilar or biogeneric counterparts, as evidenced by the recent emphasis on international public meetings to discuss such biosimilar products.
