Kim Won Seog, Ogura Michinori, Kwon Hyuk-Chan, Choi Dasom
Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.
Department of Hematology, Tokai Central Hospital, Gifu, Kakamigahara, Japan.
Future Oncol. 2017 May;13(15s):17-29. doi: 10.2217/fon-2017-0154.
As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic. We discuss these considerations and refer to recent experiences with CT-P13, a biosimilar of the TNF inhibitor infliximab used to treat rheumatoid arthritis and other inflammatory disorders.
随着许多生物抗癌药物的专利到期，预计生物类似药的使用将显著增长，这为帮助应对不断上涨的治疗成本以及增加患者获得生物疗法的机会提供了契机。获得监管批准需要针对每个参照产品进行大量非临床和临床对比研究，这只是实现生物类似药潜在益处的诸多障碍之一。若要使生物类似药在临床中被接受并广泛使用，了解不同利益相关者当前的看法和信息需求很重要。我们讨论了这些考量因素，并提及了CT-P13的近期经验，CT-P13是一种用于治疗类风湿性关节炎和其他炎症性疾病的肿瘤坏死因子抑制剂英夫利昔单抗的生物类似药。
