Consistency of Product Quality for SB5, an Adalimumab Biosimilar.

ABSTRACT:

Background

Biologics, regardless of whether they are biosimilars or reference products, are inherently variable due to their size, complexity, and the manufacturing process involved to produce them. Since a drift or evolution of quality attributes of a biologic may impact its clinical safety or efficacy, it is critical for the manufacturer to carefully control the manufacturing process and monitor the quality attributes of a biologic.

Objective

The aim of this study was to demonstrate that the quality profile of the SB5 drug product has been consistent over its production history from 2013 to 2022. SB5 is a biosimilar referencing adalimumab (Humira, trademark of AbbVie Biotechnology Ltd) and SB5 has been approved by 14 regulatory authorities including the European Commission

SUBMITTER: Lee JJ 

PROVIDER: S-EPMC9971099 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature