Industry views of biosimilar development in Japan

• Published in: Health policy (Amsterdam) Vol. 91; no. 2; pp. 189 - 194
• Main Authors: Horikawa, Hiroshi, Tsubouchi, Mina, Kawakami, Koji
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 01.07.2009; Elsevier
• Series: Health Policy
• Subjects: Attitudes; Biopharmaceuticals; Biopharmaceutics; Biosimilars; Biosimilars Follow-on proteins Regulatory guideline Interview survey Biopharmaceuticals; Biotechnology; Competition; Cost analysis; Drug industry; Drug Industry - legislation & jurisprudence; Drugs, Generic - supply & distribution; Follow-on proteins; Health administration; Incentives; Innovation; Internal Medicine; Interview survey; Interviews as Topic; Japan; Pharmaceutical industry; Pharmaceutical Preparations - economics; Regulation; Regulatory guideline; Japan; Biosimilars; Regulatory guideline; Follow-on proteins; Biopharmaceuticals; Interview survey
• ISSN: 0168-8510; 1872-6054
• DOI: 10.1016/j.healthpol.2008.12.003

Abstract 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.