Grieshaber-Bouyer R, Lorenz H-M
Medizinische Klinik V, Klinik für Hämatologie, Onkologie und Rheumatologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Deutschland.
Internist (Berl). 2020 May;61(5):522-529. doi: 10.1007/s00108-020-00784-2.
Biologic therapies are a key component of modern medicine, especially in the treatment of chronic conditions and in particular immune-mediated diseases. Biosimilars are molecularly highly similar variants of biologic therapies approved after patent expiration of the original product.
To provide an overview of the emerging role of biosimilars and present data with respect to efficacy and safety.
Since the approval of human insulin as the first biologic therapy, over 150 biologic therapeutics have been approved in the European Union (EU). Due to the high cost of development and production, biologic therapies place a heavy burden on healthcare systems and, at costs totaling 13.8 billion Euros annually, comprise one third of the annual drug expenditure in Germany. Biosimilars are highly similar versions of already approved biologic therapies that do not have clinically relevant differences with respect to efficacy, safety and immunogenicity, as far as can currently be ascertained. Through competition with the original product, biosimilars have been able to drive down prices and relieve the healthcare system without changing overall efficacy. The potential savings through biosimilars are estimated to be 500 million Euros in Germany alone. Currently, over 50 biosimilars of 16 different biologic therapies are approved in the EU.
Biosimilars are safe and economical alternatives to biooriginal drugs that can boost access to modern, high-cost therapies and relieve healthcare systems.
生物疗法是现代医学的关键组成部分，尤其在慢性病治疗，特别是免疫介导疾病的治疗中。生物类似药是在原产品专利到期后获批的分子结构高度相似的生物疗法变体。
概述生物类似药的新兴作用，并展示有关其疗效和安全性的数据。
自人类胰岛素作为首个生物疗法获批以来，欧盟已批准了150多种生物治疗药物。由于研发和生产成本高昂，生物疗法给医疗系统带来了沉重负担，在德国，其每年总成本达138亿欧元，占年度药品支出的三分之一。就目前所能确定的情况而言，生物类似药是已获批生物疗法的高度相似版本，在疗效、安全性和免疫原性方面没有临床相关差异。通过与原产品竞争，生物类似药在不改变总体疗效的情况下降低了价格，减轻了医疗系统的负担。仅在德国，通过生物类似药节省的潜在费用估计就达5亿欧元。目前，欧盟已批准了16种不同生物疗法的50多种生物类似药。
生物类似药是生物原研药安全且经济的替代品，可增加获得现代高成本疗法的机会，并减轻医疗系统负担。
