OBJECTIVES

This study aims to suggest implications for biosimiliar policy by analyzing the market competition of biosimilar in a variety of ways.

METHODS

As of April 1 2019, we analysed NHIS(National Health Insurance Service) claim volume(based on Daily Defined Dose) & amount data based on medicine listed as biosimilar reference(original) in MFDS(Ministry of Federal Drug & Safety). The analysis period was 5 years(2014 year ~ 2018 year), and the unit of analysis was the same ingredient. In the same ingredient, we divided biosimiliar, 'original', 'follow on original'. Original has the same content with biosimilar, but Follow on original has the different content with biosimilar and was listed after original

RESULTS

11 ingredients' biosimilar comparator was designated by MFDS, of which 5 ingredients(infliximab, etanercept, rituximab, trastuzumab, insulin glargine)' patent have been expired, and biosmilar was listed in NHIS formulary. The average growth rate of claim volume over the five-year period was 115.4 percent for biosimilar, -12.4 percent for original, 124.7 percent for follow on original, 0.8 percent for overall. For the average share of claim amount by each ingredient, biosimilar have increased from 3.6% in 2014 to 11.5%, while follow on original increased from 1.0% to 26.3%. The share of biosimilar claim volume also increased from 3.8% to 12.3%, while the share of follow on original claim volume increased from 0.6% to 20.5%.

CONCLUSIONS

Since the change in NHIS volume and amount data before and after the biosimilar entry was not significant, the entry of biosimilar may have a market substitution effect rather than a market expansion effect. In addition, while the entry of biosimilar may have budget saving effect because of the reduction of original and biosimilar prices. But, the entry of follow on original was a limiting factor in reducing the share of biosimilars.