With the projected expansion of the biosimilars market, clinicians must assimilate many important issues. These include understanding biosimilar development, building strategies for biosimilar introduction, and developing robust systems for biosimilar pharmacovigilance. With ten tumour necrosis factor inhibitors, a first rituximab biosimilar now on the market, and many more biosimilars currently in development, controversial issues such as multiple biosimilar switching and indication extrapolation also require consideration. In ‘ The Biosimilar Approval Process: How different is it ?’, Isaacs et al explore the sophisticated biosimilar manufacturing process and the regulatory requirements for …

中文翻译：

---

考虑在炎症性疾病中使用生物仿制药

随着生物仿制药市场的预期扩张，临床医生必须同化许多重要问题。其中包括了解生物类似药的开发、制定生物类似药引进策略以及开发强大的生物类似药药物警戒系统。随着十种肿瘤坏死因子抑制剂、第一个上市的利妥昔单抗生物类似药以及更多正在开发的生物类似药，多种生物类似药转换和适应症外推等有争议的问题也需要考虑。在“生物仿制药批准流程：它有何不同？”中，Isaacs 等人探讨了复杂的生物仿制药制造流程和监管要求……