Regulatory Requirements and Drug Prices of Biosimilars in Japan

As explained in the article, “バイオシミラー|AnswersNews Plus (” released by AnswersNews on November 21, 2018, a biosimilar is a drug with the same quality, safety, and efficacy as a reference biopharmaceutical product. It is developed by a different company (not the company that is marketing the originator) after the patent for the reference product has expired. To demonstrate clinical equivalence and similarity to the reference product, clinical trials enrolling actual patients are required even if the development process of biosimilars is not equivalent to that of the reference product. The price of a biosimilar is typically higher than that of a typical generic product due to the high costs associated with development and manufacturing. However, it is typically 70% of the price of the reference biopharmaceutical product. For subsequent biosimilars, the price tends to be proportional to the price of biosimilars already on the market. And also, current updates on government policy indicate a supportive trend for biosimilars.