Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States

Abstract

(1) Background: Drug lag, the delay between the first global regulatory approval and approval by the national health authorities in other countries, impacts the accessibility of drugs. Although the Korean pharmaceutical market has grown significantly, most of its innovative drugs for public health depend on imports from foreign pharmaceutical markets. (2) Methods: We extracted data from the official websites of the Korean Ministry of Food and Drug Safety (MFDS) and the US Food and Drug Administration. Information on new molecule entity drugs, approved as imported drugs by MFDS from 2000 to 2019, was extracted. Multivariate Cox proportional hazard models on drug approval were estimated. (3) Results: In total, 424 drugs were analyzed. Orphan drugs designated by MFDS were less likely to receive approval (HR = 0.731, 95% CI: 0.572–0.934). The drugs with Korean MAHs were less likely to obtain drug approval than those with MAHs of subsidiaries of multinational pharmaceutical companies (HR = 0.524, 95% CI: 0.371–0.738). In the analyses for non-orphan drugs (n = 37), oncology drugs that need local clinical study (HR = 0.247, 95% CI: 0.093–0.657) and drugs that need more patients in a local clinical study (HR = 0.993, 95% CI: 0.988–0.999) were less likely to receive approval, with longer drug lag. The higher number of clinical studies in Korea was associated with a shorter drug lag (HR = 2.133, 95% CI: 1.196–3.805). (4) Conclusions: Our findings imply that Korean pharmaceutical companies should augment their research capabilities for new drug development. Furthermore, consideration of orphan drugs used in rare diseases is needed for drug approval to ensure the availability of these drugs in the market without approval delays.

Trends and Clinical Characteristics of Next-Generation Sequencing–Based Genetic Panel Tests: An Analysis of Korean Nationwide Claims Data

“…Furthermore, the average drug lag was 14.8 months in A9 countries compared to 27 months in South Korea [ 22 ]. A study analyzing approved imported drugs in South Korea from 2000 to 2019 found that oncology drugs were 0.247 times less likely to receive approval than non-oncology drugs [ 23 ]. Therefore, the approval and insurance coverage of new anticancer drugs must be more actively pursued, while health policies should move to ease regulations on new drugs or clinical trials, thus encouraging investigator- or sponsor-initiated clinical trials.…”

International comparison of availability for orphan drugs: focused on approved orphan drugs in South Korea

“…That is, the benefits are concentrated in the later stages, when development has progressed considerably, rather than promoting the R&D of orphan drugs. Therefore, as the environment continues to rely on imported orphan drugs, the drug lag may intensify, which is a similar phenomenon occurring in Japan, which has an orphan designation and approval process similar to those of South Korea (Cho & Han, 2022 ; Miyazaki et al, 2022 ).…”

Trends and Characteristics of New Drug Approvals in China, 2011–2021

“…Drug lag is often used as a measure of how far behind patients in one country have access to the newest or the most advanced therapies compared with those in other countries [ 19 , 20 ]. Our findings suggest that in recent years, the proportion of new drugs approved in China with shorter drug lags has increased and the proportion of those with longer drug lags has decreased.…”