제네릭 의약품 제도 변화에 따른 광의의 위임형 제네릭 허가 현황 분석

Analysis of the Approval Status of Authorized Generics in a Broad Sense Following Revisions to the Generic Drug System

The social demand for improved raw material quality management and control of generic drug proliferation led to changes in the system, including differentiated pricing from July 1, 2020, and the 1+3 system limiting products with identical bioequivalence data from July 20, 2021. This study examined the impact of these reforms on the approval of authorized generics in a broad sense. The analysis data was constructed from sources such as the generic drug bundle list, domestic pharmaceutical patent status, and the Korea Pharmaceutical Information Center. The study found that Phase II (July 2019 to June 2020, just before the drug pricing reform) had the highest number of approvals, with 180 cases, reflecting a 2.6-fold increase from the baseline in Phase I (July 2018 to June 2019, before the reform impact), which had 70 approvals. When the drug pricing reform was implemented in Phase III (July 2020 to June 2021), approvals dropped to 57, or 0.8 times the baseline. This decline continued in Phase IV (July 2021 to June 2022), marking the start of a second reform with the approval system change, which saw approvals fall to 48, or 0.7 times the baseline. In Phase V (July 2022 to June 2023, after the full implementation of the approval reform), approvals further dropped to 45, or 0.6 times the baseline. The findings indicate that these reforms acted as regulatory barriers, limiting new authorized generics in a broad sense.