Department of Dermatology, University of Connecticut School of Medicine, Farmington, Connecticut 06032, USA.
J Am Acad Dermatol. 2012 Feb;66(2):317-22. doi: 10.1016/j.jaad.2011.08.034.
The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not equivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide.
生物类似药形式的生物制药疗法进入市场，用于治疗银屑病和其他免疫介导性疾病，这引发了极大的关注。尽管皮肤科医生已经习惯使用各种通用的局部制剂，但为了支持最佳治疗管理和患者护理，有必要认识到原药（即名牌药）与通用药或生物类似药之间的关键差异。在这篇综述中，我们总结了生物类似药即将引入皮肤科领域的最新进展。生物类似药是一种重要的干预措施，其价格更便宜，因此有可能使大量目前无法获得这些治疗药物的患者受益。但是，生物类似药的开发与小分子通用疗法不同，因为其分子结构和制造过程存在差异。计划的监管指导方针和审批途径可能无法涵盖所有这些潜在的重要差异，这可能对处方医生和患者具有临床意义。因此，我们确定了一系列关键问题，这些问题应得到考虑，以充分发挥生物类似药在治疗银屑病方面的潜力，即增加全球银屑病患者获得适当治疗的机会。
