Dataset Information

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, including purity, post-translational glycosylation (SB4 only), protein concentration, and biological activity.

Results

The protein concentration, purity, tumor necrosis factor-α (TNF-α) binding, and TNF-α neutralization of all batches of SB4 and SB2 were within the strict specification limits set by regulatory agencies, as was the total sialic acid (TSA) content of all batches of SB4.

Conclusions

Quality attributes of SB4 and SB2 batches showed little variation and were consistently within the rigorous specifications defined by regulatory agencies.

SUBMITTER: Ebbers HC

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

REPOSITORIES: biostudies-literature

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Publications

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

Ebbers Hans C HC Fehrmann Bjørn B Ottosen Mette M Hvorslev Niels N Høier Pia P Hwang Jae-Woong JW Chung Jinhan J Lim Hyoung Taek HT Lee Shinjung S Hong Juyoung J Rezk Mourad Farouk MF

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20200401 2

<h4>Background</h4>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).<h4>Methods</h4>SB4 (Be ...[more]

PMID: 31925703

Similar Datasets

Project description:IntroductionIn 2016, SB4 (Benepali®) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice.MethodsA systematic search for publications on real-world evidence of SB4 effectiveness, safety and drug survival was undertaken using search terms (SB4 OR Benepali OR biosimilar etanercept OR innovator etanercept) in the BIOSIS® Toxicology, BIOSIS Previews®, Embase® and MEDLINE® databases up to 17 January 2019.ResultsOf 959 articles identified, eight journal articles, two journal letters and 23 congress abstracts were selected on criteria of original real-world evidence with a clinical focus. As expected with real-world evidence, quality scoring showed that the evidence had high external validity but lower internal validity. A total of 13,552 patients were described across nine European countries and all approved SB4 indications: 2499 were ETN-naïve and 11,053 switched from reference ETN to SB4 (switchers). Switch acceptance rates (a combination of clinicians offering and patients accepting initiation on SB4) ranged between 51.6% and 99.0%; patient support programmes positively contributed to acceptance. Disease activity was generally similar pre- and post-switch (typically 3-month timeframe). Retention rates across studies were at least 75% (up to 12 months follow-up). No new safety signals were identified. Differences in discontinuation rates versus historic controls reported in some studies may have been influenced by differences in treatment practices, lack of clinician confidence and nocebo effects.ConclusionNearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients.FundingBiogen International GmbH.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

Similar Datasets

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