OBJECTIVES : The European Union (EU) is currently the most advanced biosimilar market (54 biosimilars approved). While the European Medicines Agency (EMA) published a biosimilar framework in 2005, Japan and the United States (USA) developed their guidelines in 2009, and the number of approved biosimilars in these countries remains relatively small (21 and 26, respectively). China entered the market in 2019 with the first biosimilar approved in line with the guidelines published in 2015. However, the copy-biologics, not meeting the criteria for biosimilars, have been available in China for a long time. The aim of this research was to compare the status of policies targeting adoption of biosimilars, i.e., interchangeability, switching and substitution in the EU5, the USA, Japan and China.

METHODS : A comprehensive review of the literature in medical databases (Medline and Embase) and grey literature was conducted to obtain key English language publications providing most recent information on biosimilar policies.

RESULTS : While in the EU5 physician-led switching is allowed ensuring an accurate monitoring, automatic substitution is still not legally approved. In the USA, switching is allowed and products approved by Food and Drug Agency (FDA) as interchangeable can be automatically substituted, although no biosimilar has been approved as interchangeable product yet. In Japan, switching was not recommended by 2009 guidelines and automatic substitution is not possible, but health policy promotes biosimilar use as the recent trend. Currently, in China, there is no regulation of interchangeability, switching and substitution.

CONCLUSIONS : While the EU is the most advanced region in the field of biosimilars, China remains less regulated market. Automatic substitution is not formally implemented in any analyzed country. However, the lack of regulation regarding biosimilar in China indicates that automatic substitution may happen, in contrast to more regulated markets such as US, EU and Japan.