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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V2-S6] Patient-Oriented Evolution on Biosimilars: Challenges in Regulatory Science, R&D and Medical Practice

Session Chair(s)

Yoshihiro  Nambu, MD, PhD

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

Current Status of Biosimilars in Japan

Teruyo Arato, PhD

Hokkaido University Hospital, Japan

Professor, Clinical Research and Medical Innovation Center

Kyoko  Sakurai, PharmD

Regulatory Status of Biosimilars in Japan

Kyoko Sakurai, PharmD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Reviewer, Office of Cellular and Tissue-Based Products

Hiroshi  Anekawa

How We Should Realize Expectations to Biosimilar

Hiroshi Anekawa

Nippon Kayaku Co., Ltd., Japan

General Manager, Department of Medical Affairs, Pharmaceutical Group

Itsuko  Ishii, PhD

Trends in Usage of Biosimilars at Chiba University Hospital

Itsuko Ishii, PhD

Chiba University Hospital, Japan

Professor/Chairman, Department of Pharmacy

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