Technical considerations on non-clinical study and evaluation for biosimilar products / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate biosimilar products focus on the similarities in the quality, safety and eificacy between the candidate and reference products. METHODS: Comparative non-clinical studies should be conducted and stepwise development should be carried out to demonstrate the similarity in non-clinical study for the candidate and reference products. Usually the necessity and content of in vivo study are dependent on the results of previous comparative studies in vitro. RESULTS AND CONCLUSION: Determination of the non-clinical similarity should be based on the statistical analysis of the candidate and reference products. Evaluation for toxicity similarities can focus on toxicity profile in types and extent. The non-clinical similarities will affect the strategy of clinical trial for biosimilars.