Considerations for design and evaluation of clinical similarity comparison trial of biosimilars / 中国药学杂志

ABSTRACT

OBJECTIVE: To discuss the key considerations and evaluation criteria in designing a clinical comparison study to assess the clinical similarity of biosimilars. METHOD: Relevant guidelines and literatures on clinical similarity evaluation were reviewed, the cases were analyzed, discussions were carried out with biotech industry sponsors and clinical and statistical experts, the key considerations and evaluation criteria were proposed for assessing the clinical similarity of biosimilars. RESULTS AND CONCLUSION: The clinical similarity criteria should reflect the characteristics of the biological products. It is critical to select right patient population, clinical endpoints and equivalence/non-inferiority margin for development of different biosimilar products on the basis of fully understanding the quality, efficacy and safety profile of the original biological products. To set up the clinical similarity criterion and selection of the equivalence/non-inferiority margin, the consistency of the therapeutic effect of the reference product and subject variability need to be taken into consideration for robust evaluation of clinical similarity.