Despite their availability for over a decade, the exact nature of biosimilar medicines is still poorly understood with paucity of clear treatment guidelines for their use in clinical practice in Australia. Although hematologists have had experience with biosimilars in the setting of supportive care, with the approval of the first biosimilar rituximab in hematological malignancies, it is important to revisit this topic. To inform the use of biosimilar medicines in clinical practice, we have developed a consensus statement from an Expert Panel of Australian hematologists, oncologists, and cancer pharmacists. These recommendations address the approach to use of biosimilar products in place of the corresponding reference medicine in a number of different clinical contexts. Our recommendations are based on the premise that biosimilar medicines can be considered therapeutically equivalent to their reference brand and used in a similar way to the reference product in any approved indication. We advocate for local approaches to the provision of patient information, dispensing of the intended brand and pharmacovigilance, to be developed in consultation with local hematologists and aim to improve confidence in the appropriate use of biosimilar medicines and their expected outcomes among hematologists.

中文翻译：

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关于在澳大利亚血液学中使用生物仿制药的共识性声明。

尽管已有十多年的历史，但由于缺乏在澳大利亚临床实践中使用明确的治疗指南，生物仿制药的确切性质仍知之甚少。尽管血液学家在支持治疗方面具有生物仿制药的经验，但在血液恶性肿瘤中首个生物仿制药利妥昔单抗的批准后，重新审视这一主题很重要。为了向临床实践中生物仿制药的使用提供信息，我们已经获得了澳大利亚血液学家，肿瘤学家和癌症药剂师专家小组的共识声明。这些建议解决了在许多不同的临床环境中使用生物仿制药替代相应参考药物的方法。我们的建议是基于这样的前提：生物仿制药在治疗上可以等同于其参考品牌，并且在任何批准的适应症中都可以与参考产品类似地使用。我们提倡在与当地血液学家协商后开发用于提供患者信息，分配预期品牌和进行药物警戒的本地方法，旨在提高血液学家对生物仿制药的合理使用及其预期结果的信心。