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. CONCLUSION: 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.
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. CONCLUSION: 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.