What Physicians Need to Know About Biosimilars
BMY Cheung
Hong Kong J Radiol 2013;16(Suppl):S50-4
Biologics are complex proteins derived from living organisms that have been used successfully in treating many different diseases. As some biologics approach patent expiration, the development of drugs that are similar to the approved biological agents, known as biosimilars, has gained significant interest, primarily as a more affordable option for patients. Because of the structural complexity of large proteins and the inherent heterogeneity associated with culturing and manufacturing conditions, biosimilars are highly similar, but not identical to the approved ‘reference’ agents. Any subtle changes in the manufacturing processes may result in altered function and immunogenicity of the biosimilars, potentially affecting their efficacy and safety profile. Thus, stringent regulatory framework and requirements are necessary to ensure biosimilars are comparable in quality, efficacy, and safety with the reference agents and suitable for clinical use. As this field continues to evolve and more biosimilars are expected to become available in the near future, physicians will need to make informed decisions in the clinical use of biosimilars to ensure that high-quality, safe, and affordable drugs are accessible to patients. This article summarises current considerations, regulatory processes, and challenges in this rapidly evolving field.
中文摘要
關於生物製劑的醫生需知
張文勇
生物製劑是來源自活生物的蛋白複合物，已被成功用於治療多種不同疾病。由於部分生物製劑的專利即將期滿，一些與獲批生物製劑相似、稱為生物仿製藥的藥物發展備受關注，成為對病人而言更能負擔的選擇。因為大蛋白質的結構複雜，加上與培植及生產環境相關的變數，所以雖然生物仿製藥與獲認可的「參考」藥物高度相似，但並非完全相同。在製造過程中任何細微的變化，都可能改變生物仿製藥的功能及免疫原性，而可能影響其療效和安全性。因此，必須要有嚴格的監管框架及要求，以確保生物仿製藥與參考藥物在品質、療效及安全性相若，並適合臨床使用。隨着這領域的不斷發展，在不久將來會有更多生物仿製藥面世，醫生將需要在使用生物仿製藥上作出明智的決策，以確保患者可獲得高品質、安全而且負擔得起的藥物。本文總結了在這個正在迅速演變的領域中現今的顧慮、監管程序和挑戰。