Licensing of biosimilars is essential to promote patient access to 21st-century biological medicines. Regulatory approval of biosimilars is based on the totality of evidence from a head-to-head comparison with reference products (RPs). A clinical efficacy trial is usually required, but this is increasingly questioned. Based on a thorough review of biosimilar applications in the European Union (EU), we conclude that in-depth knowledge of the reference product, allied with high-performing analytical tools, largely predicts clinical comparability, subject to confirmation by a comparative pharmacokinetic (PK) trial. We provide a blueprint for a biosimilar pathway that reduces the need for clinical efficacy trials in exceptional cases, together with qualifying criteria and requirements for streamlined assessment to expedite wider access to affordable biological medicines.

生物仿制药的许可对促进患者获得21世纪生物药品至关重要。生物仿制药的监管批准是基于与参考产品（RP）进行正面对比的全部证据。通常需要进行临床疗效试验，但这受到越来越多的质疑。基于对欧盟（EU）中生物仿制药应用的全面审查，我们得出结论，对参考产品的深入了解以及高性能的分析工具，在很大程度上可预测临床可比性，但需要经过比较药代动力学（PK）的确认）试用。我们提供了生物仿制药途径的蓝图，可减少在特殊情况下进行临床功效试验的需要，