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[V2-S6] Patient-Oriented Evolution on Biosimilars: Challenges in Regulatory Science, R&D and Medical Practice
Session Chair(s)
Yoshihiro Nambu, MD, PhD
Member of The Board / Managing Director / Head of Pharmaceuticals Group, Nippon Kayaku Co., Ltd., Japan
Biosimilars (BS) have been actively developed under recently-established biosimilar guidelines in the EU, US, and Japan while medical costs are soaring and patents of expensive innovator biopharmaceuticals are expiring. Neither the provider side (represented by physicians, pharmacists, and nurses) or the beneficiary side (represented by patients) clearly recognize BS, while expectations of improving the regulatory process, containing medical expenditures and promoting the pharmaceutical industry continue to swell. This session will present current regulatory, R&D and medical practices, especially the package insert descriptions in Japan compared to those in the EU and US, provide appropriate regulatory compliance information, and further the promotion of BS and biotechnology.
Speaker(s)
Teruyo Arato, PhD
Professor, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan
Current Status of Biosimilars in Japan
Kyoko Sakurai, PharmD
Reviewer, Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Status of Biosimilars in Japan
Hiroshi Anekawa
General Manager, Department of Medical Affairs, Pharmaceutical Group, Nippon Kayaku Co., Ltd., Japan
How We Should Realize Expectations to Biosimilar
Itsuko Ishii, PhD
Professor/Chairman, Department of Pharmacy, Chiba University Hospital, Japan
Trends in Usage of Biosimilars at Chiba University Hospital