TY - JOUR
T1 - Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan
AU - Hino, Yoshitsugu
AU - Okada, Miu
AU - Hallgreen, Christine Erikstrup
AU - De Bruin, Marie Louise
AU - Doty, Randell E.
AU - Matsumaru, Naoki
AU - Tsukamoto, Katsura
N1 - Publisher Copyright:
© 2023 The Pharmaceutical Society of Japan.
PY - 2023/5
Y1 - 2023/5
N2 - A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades to obtain fundamental information for understanding how the aforementioned demands are met, especially to eliminate drug lags among regions. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system. Most FIC anticancer drugs were first approved in the US. The median approval time for anticancer drugs in new pharmacological classes during the last two decades in Japan (5072d) was significantly different (p=0.043) from that in the US (4253d), though it was not significantly different from that in the EU (4655d). Submission and approval lags between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions. Even among developed countries, FIC anticancer drug lags exist. Considering the high impact of FIC anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.
AB - A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades to obtain fundamental information for understanding how the aforementioned demands are met, especially to eliminate drug lags among regions. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system. Most FIC anticancer drugs were first approved in the US. The median approval time for anticancer drugs in new pharmacological classes during the last two decades in Japan (5072d) was significantly different (p=0.043) from that in the US (4253d), though it was not significantly different from that in the EU (4655d). Submission and approval lags between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions. Even among developed countries, FIC anticancer drug lags exist. Considering the high impact of FIC anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.
KW - anticancer
KW - drug development
KW - drug lag
KW - first-in-class
KW - regulatory policy
UR - http://www.scopus.com/inward/record.url?scp=85159251598&partnerID=8YFLogxK
U2 - 10.1248/bpb.b22-00868
DO - 10.1248/bpb.b22-00868
M3 - Article
C2 - 36878610
SN - 0918-6158
VL - 46
SP - 700
EP - 706
JO - Biological and Pharmaceutical Bulletin
JF - Biological and Pharmaceutical Bulletin
IS - 5
ER -