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
Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo (Michael) Jakovljevic, MD, PhD, MAE
Page: 163-6Abstract: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 provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg […]
US interchangeability designation: are we ready to cut the Gordian knot?
Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD
Page: 160-2Abstract: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 as quality, safety and efficacy are established by biosimilarity already. Approval pathways for biosimilars and interchangeable […]
