Pohlscheidt Michael, Kiss Robert, Gottschalk Uwe
Biogen International GmbH, International Manufacturing, Zug, Switzerland.
Adv Biochem Eng Biotechnol. 2018;165:1-8. doi: 10.1007/10_2017_39.
The production of the first therapeutic proteins in the early 1980s heralded the launch of the biopharmaceuticals industry. The number of approved products has grown year on year over the past three decades to now represent a significant share of the entire pharmaceuticals market. More than 200 therapeutic proteins have been approved, approximately a quarter of which are represented by monoclonal antibodies and their derivatives. In 2016, the list of the top 15 best-selling drugs included more than eight biologics and in 2020 the trend will continue, with more than 50% of the top 20 best-selling drugs predicted to be biologics. From 1986 to 2014 several first-in-class, advance-in-class, and breakthrough designated therapeutic options were approved, with advanced therapies such as immuno-oncology and cell-based therapies being approved for several indications.
20世纪80年代初首批治疗性蛋白质的生产标志着生物制药行业的兴起。在过去三十年里，获批产品的数量逐年增长，如今在整个药品市场中占据了相当大的份额。已有200多种治疗性蛋白质获得批准，其中约四分之一是单克隆抗体及其衍生物。2016年，最畅销的15种药物中，生物制剂超过8种，到2020年这一趋势仍将持续，预计最畅销的20种药物中有超过50%将是生物制剂。从1986年到2014年，多种同类首创、同类领先和突破性指定治疗方案获得批准，免疫肿瘤学和细胞疗法等先进疗法也被批准用于多种适应症。
