OBJECTIVE：To explore the development status of regulatory policies of biosimilars in foreign countries，and to provide reference for perfecting biosimilars regulatory policies in China. METHODS：Comparative analysis was conducted，concerning biosimilar regulations and directories which had been issued by WHO，EMA and FDA，in aspects of biosimilars definition， the choice of reference drug，quality studies，non-clinical studies，clinical studies. RESULTS & CONCLUSIONS：Three common points found in foreign regulatory policies were that：firstly，discrepancies were allowed between biosimilars and reference drugs； secondly，the comparison was itemized between biosimilars and reference drugs on safety and effectiveness，in order to guarantee the reliability of quality research；thirdly，clinical and non-clinical studies were reduced with a premise that similarity is confirmed. Given China’s current situation，several parts of policies should be improved，including stressing pertinence of reference drug selection， refining preclinical and clinical study directories and establishing supporting system after listing.