Work

A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes

Year: 2025

Type: article

Abstract: Intravenous immunoglobulin (IVIg) product is a pooled human plasma-derived IgG medicinal product indicated for various immunodeficiency and autoimmune diseases. These indications have essentially been approved in Japan based on clinical evaluations of each product, but a harmonization or standardization of IVIg products would be helpful. We introduce a new Japanese regulatory perspective on the extrapolation of indications for approved IVIg products from a reference product composed of intact IgG (chemically unmodified full-length IgG) based on the consideration of the mode of action (MOA), a quality-comparability analysis, and the post-marketing clinical track record's re-examination regarding the products' efficacy and safety.

Source: Biologicals

DOI: 10.1016/j.biologicals.2025.101860

Authors: Takashi Kameda, Kazuki Nagashima, Shun Masuta, Teruhide Yamaguchi, Michihiro Ogawa

Institutions: Pharmaceuticals and Medical Devices Agency, Nihon Pharmaceutical University

Language: English