A Biosimilar is a biotechnology–derived product (biologic) which is comparable to an approved biologic in terms of quality, safety and efficacy. Biosimilars are different from generic drugs, which are bioequivalent to the original with identical active ingredients. Biosimilars are made from proteins which have a much more complicated molecular structure and therefore, exact copies cannot be made. Nowadays, biosimilars are gaining a lot of attention as several major biologic medicines are nearing their patent expiration and real world evidence of usage of biosimilars is accumulating in European countries, where the biosimilar infrastructure is more advanced than in the US and Japan.

Considering that Japan is facing soaring healthcare costs, biosimilars are expected to have a critical role to play in ensuring a sustainable healthcare system. In this respect, swift action should be taken to develop an infrastructure to encourage proper usage of biosimilars by increasing the correct understanding of biosimilars among healthcare providers and developing appropriate policies to promote biosimilar use across society.