GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 13 / Year 2024 / Issue 3
Perspective
The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies
Page: 164-7Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4, Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD Abstract: This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It […]
US interchangeability designation: are we ready to cut the Gordian knot?
Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD
Page: 161-3Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching studies are not generally needed for the interchangeability designation […]
