Celltrion Healthcare , Incheon, Republic of Korea.
Department of Pharmacology, College of Medicine, Chung-Ang University , Seoul, Republic of Korea.
MAbs. 2021 Jan-Dec;13(1):1868078. doi: 10.1080/19420862.2020.1868078.
The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as "biobetters" or "value-added medicines," are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients.
生物类似药的概念现已得到广泛认可。在获得批准之前和之后积累的临床数据支持了生物类似药的应用,这反过来又刺激了生物制品市场的竞争,并增加了患者获得生物制品的机会。随着技术的进步,其他创新型生物制品,如“生物改良药”或“增值药物”,现已推向市场。这些创新型生物制品与参比产品的不同之处在于提供了额外的临床或非临床效益。我们将参考 CT-P13 来讨论这些创新型生物制品,CT-P13 最初是作为参考药物英夫利昔单抗的静脉(IV)生物类似药上市的。现在已经开发出了 CT-P13 的皮下(SC)制剂 CT-P13 SC。与 CT-P13 IV 相比,CT-P13 SC 在药代动力学方面具有临床优势,具有相当的疗效、安全性和免疫原性,同时也为患者提供了便利,并减少了对医疗系统资源的需求。与生物类似药曾经的情况一样,创新型生物制品的命名和监管途径需要明确,以支持其应用,并最终使患者受益。