Ludwig W D, Dicheva S
Klinik für Hämatologie, Onkologie, Tumorimmunologie, HELIOS Klinikum Berlin-Buch, Berlin, Germany.
Arzneimittelkommission der deutschen Ärzteschaft, Berlin, Germany.
Z Gastroenterol. 2016 Nov;54(11):1223-1229. doi: 10.1055/s-0042-117650. Epub 2016 Oct 10.
Biosimilar medicinal products (biosimilars) have been available in Europe for 10 years, allowing a wide use particularly in oncology. Biosimilars are being developed and approved by means of scientifically sound principles to assure close similarity with the reference products with regard to quality, efficacy, and safety. The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an already licensed biological. Nevertheless, many clinicians voiced concerns about biosimilars related to their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity), and interchangeability with the originator product. The availability of biosimilars would strengthen the economic competition on the pharmaceutical market, provide opportunities to improve healthcare access, and contribute to the financial sustainability of European healthcare systems. Biosimilars can be considered therapeutic alternatives to the reference product. To date, no data has been published revealing any disadvantages of the biosimilars' use. This article aims to acquaint clinicians, particularly oncologists and haematologists, with the biosimilar concept as they are going to be confronted with a constantly increasing number of biosimilars due to patent expirations in the near future. Furthermore, it provides information on scientific principles guiding biosimilar development and regulatory requirements. This should minimise unfounded fears and concerns among clinicians. Additionally, we provide information on the interchangeability between originator products and biosimilars to assist clinicians in making evidence-based, appropriate, and cost-effective treatment choices for their patients.
生物类似药在欧洲已上市10年，在肿瘤学等领域得到了广泛应用。生物类似药是依据科学合理的原则研发并获批的，以确保在质量、疗效和安全性方面与参照产品高度相似。确立生物相似性的科学原则与已获许可生物制品生产工艺变更后证明可比性的原则相同。然而，许多临床医生对生物类似药在药品质量、疗效（尤其是外推适应症方面）、安全性（特别是免疫原性）以及与原研产品的可互换性等方面表示担忧。生物类似药的出现将加剧药品市场的经济竞争，为改善医疗可及性提供机会，并有助于欧洲医疗保健系统的财务可持续性。生物类似药可被视为参照产品的治疗替代方案。迄今为止，尚未有数据表明使用生物类似药存在任何弊端。本文旨在让临床医生，尤其是肿瘤学家和血液学家，了解生物类似药的概念，因为在不久的将来，由于专利到期，他们将面临越来越多的生物类似药。此外，本文还提供了指导生物类似药研发的科学原则和监管要求的相关信息。这应能最大程度减少临床医生毫无根据的恐惧和担忧。此外，我们还提供了原研产品与生物类似药之间可互换性的信息，以协助临床医生为患者做出基于证据、恰当且具有成本效益的治疗选择。
