Gupta Vishal, Khaitan Binod K
Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.
Indian J Dermatol Venereol Leprol. 2015 Sep-Oct;81(5):451-6. doi: 10.4103/0378-6323.163706.
The introduction of biologic therapy has revolutionized the treatment of many chronic diseases, including several dermatological disorders. Biological agents promise to satisfy medical needs previously unmet by conventional medicines. Unfortunately, these agents are expensive and out of reach for the majority of patients who need them. Biosimilars are copies of the innovator biological agents and represent an important advance in the field of biological therapeutics. Although they are similar to the original biologic, differences in terms of structure, efficacy, safety and immunogenicity remain a concern. Thus, biosimilars cannot be regarded as bio-generics. Awareness of the key differences between a biosimilar and its reference biological agent is essential for optimal treatment and safety of patients. The increasing availability of biosimilars provides patients and doctors with less expensive alternatives and increases the accessibility of biologic therapy to needy patients. In this review, we discuss the concept of biosimilars, the need for appropriate regulatory pathways and their current status in dermatology.
生物疗法的引入彻底改变了许多慢性疾病的治疗方式,包括几种皮肤病。生物制剂有望满足传统药物以前未满足的医疗需求。不幸的是,这些药物价格昂贵,大多数需要它们的患者难以企及。生物类似药是创新生物制剂的仿制品,代表了生物治疗领域的一项重要进展。尽管它们与原始生物制剂相似,但在结构、疗效、安全性和免疫原性方面的差异仍然令人担忧。因此,生物类似药不能被视为生物仿制药。了解生物类似药与其参照生物制剂之间的关键差异对于患者的最佳治疗和安全至关重要。生物类似药可用性的增加为患者和医生提供了更便宜的选择,并增加了有需要的患者获得生物治疗的机会。在这篇综述中,我们讨论了生物类似药的概念、适当监管途径的必要性及其在皮肤科的现状。