Industry views of biosimilar development in Japan.
OBJECTIVE
To understand the issues around biosimilar development by pharmaceutical companies in Japan, which has emerged as an urgent issue in guaranteeing the availability of affordable biopharmaceuticals and a reduction in drug costs.


METHODS
Various regulatory guidelines related to biosimilar development are carefully reviewed. We then interviewed representatives of 11 Japanese companies to explore issues related to the manufacturing, immunogenicity, development costs and regulation of biosimilars.


RESULTS
Our investigations show that Japan is unlikely to produce more than a handful of biosimilars domestically in the near future. We also found that regulatory guidelines for biosimilars will be needed for Japanese developers to plan and initiate production, in order to provide affordable biopharmaceuticals to Japanese patients.


CONCLUSIONS
These results represent that regulatory guidelines for biosimilars, encouraging competition with maintaining incentive for innovation, will be needed for Japanese developers to plan and initiate biosimilar development.
Horikawa
Hiroshi
H
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Tsubouchi
Mina
M
Kawakami
Koji
K
D001702:Biopharmaceutics; D004345:Drug Industry / Q000331:legislation & jurisprudence; D016568:Drugs, Generic / Q000600:supply & distribution; D007407:Interviews as Topic; D007564:Japan; D004364:Pharmaceutical Preparations / Q000191:economics
D016568:Drugs, Generic; D004364:Pharmaceutical Preparations