Kesik-Brodacka Malgorzata
Department of Bioengineering, Institute of Biotechnology and Antibiotics, Warsaw, Poland.
Biotechnol Appl Biochem. 2018 May;65(3):306-322. doi: 10.1002/bab.1617. Epub 2017 Nov 2.
Since its introduction in 1982, biopharmaceutical drugs have revolutionized the treatment of a broad spectrum of diseases and are increasingly used in nearly all branches of medicine. In recent years, the biopharmaceuticals market has developed much faster than the market for all drugs and is believed to have great potential for further dynamic growth because of the tremendous demand for these drugs. Biobetters, which contain altered active pharmaceutical ingredients with enhanced efficacy, will play an important role in the development of biopharmaceuticals. Another significant group of biopharmaceuticals are biosimilars. Their introduction in the European Union and, recently, the Unites States markets will reduce the costs of biopharmaceutical treatment. This review highlights recent progress in the field of biopharmaceutical development and issues concerning the registration of innovative biopharmaceuticals and biosimilars. The leading class of biopharmaceuticals, the current biopharmaceuticals market, and forecasts are also discussed.
自1982年问世以来，生物制药药物彻底改变了多种疾病的治疗方式，并越来越多地应用于几乎所有医学分支。近年来，生物制药市场的发展速度远远超过了所有药物的市场，并且由于对这些药物的巨大需求，人们认为其具有进一步动态增长的巨大潜力。生物优化药含有经过改变的活性药物成分，疗效增强，将在生物制药的发展中发挥重要作用。另一类重要的生物制药是生物类似药。它们在欧盟以及最近在美国市场的推出将降低生物制药治疗的成本。本综述重点介绍了生物制药开发领域的最新进展以及有关创新生物制药和生物类似药注册的问题。还讨论了生物制药的主要类别、当前的生物制药市场以及预测情况。
