OBJECTIVES

Consigned generic drug is a generic drug sold by a company differing from a manufacturer and having a certificate of the consigned bioequivalence test. After December 2011, the ministry of food and drug safety (MFDS) in South Korea allowed consigned generic drugs without any restriction of the number of sales companies. We aimed to investigate the approval of generic drugs, including consigned and self-manufactured generic drugs, and to compare those before and after the relaxation of regulation and their prices for last 11 years.

METHODS

We analyzed the list of bioequivalence-approved generic products from 2007 to 2017, provided by the MFDS. Only oral products were included. The restricted period, restricting sales/manufacture of consigned generic drugs, was defined as spanning from 2007 to 2011; the non-restricted period as spanning from 2012 to 2017. Generics were classified as self-manufactured or consigned generics. We compared the proportion of consigned generics between restricted/non-restricted periods. Also, we compared the relative cost that the price of self-manufactured generic or consigned bioequivalence generic against highest price among products being same ingredient and dose.

RESULTS

Of 6,586 identified oral products, 74.95% of generic drugs approved during the non-restricted period were consigned generics while 27.23% were in the restricted period. The trend showed a marked increase in the number of items licensed through the consigned bioequivalence test since 2012, with the maximum value of 88.42% in 2016. In the restricted period, the average relative price of consigned products (0.85) was higher than that of self-manufactured ones (0.78); the gap between the consigned and self-manufactured generics became less after the relaxation of regulation (0.97, 0.92).

CONCLUSIONS

To best of our knowledge, this is the first study analyzing the approval of consigned generics, which is country-specific concept.