Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

ABSTRACT:

Background

Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2).

Methods

SB4 (Benepali^®) and SB2 (Flixabi^®) were both developed by Samsung Bioepis and are manufactured in Europe by Biogen at their facility in Hillerød, Denmark. A total of 120 batches of SB4 and 25 batches of SB2 were assessed for consistency and compliance with specified release parameters

SUBMITTER: Ebbers HC 

PROVIDER: S-EPMC7113226 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature