生物类似药临床应用专家共识

生物类似药具有与参照药相似的质量、疗效和安全性,同时具有价格优势,对实现我国居民用药的更高可及性具有非常重要的意义。为加深对生物类似药这一新兴概念的正确认识,规范我国生物类似药的临床用药,共识专家组参考国内外相关循证医学证据,结合临床用药体会,经充分讨论沟通,达成以下共识:(1)生物类似药与参照药疗效等同、安全性相似,临床上可以替代使用;(2)根据“适应证外推”原则,生物类似药可获得参照药具有相同作用机制的其他所有适应证,而且对外推适应证的疗效和安全性与参照药相似;(3)对于正在接受治疗的患者,临床医生可根据患者情况,决定是否由使用参照药转换成使用生物类似药。

Expert consensus on the clinical application of biosimilars

The biosimilars have the similar quality, efficacy and safety to their reference medicines, and they have a competitive pricing, which is of great significance for realizing greater access to Chinese residents' medication. To deepen the further understanding of the novel concept of biosimilars and to standardize the clinical use of biosimilars, the consensus expert group ultimately reached the following three consensus points with the efforts of consulting relevant domestic and international evidence-based studies, combining with their clinical experience and discussing fully: firstly, biosimilars have equivalent efficacy and similar safety as reference medicine and can replace the clinical use of reference medicine; second, according to the principles of "extrapolation", biosimilars are approved for the other indications held by reference medicine with similar mechanisms of action, and the efficacy and safety of biosimilars in these indications are similar to those of the reference medicine; third, for patients currently receiving treatment, physicians can decide to switch from reference medicine to biosimilars based on the patients' conditions, which is safe and effective for treatment.