ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023
Consistency of Product Quality for SB5, an Adalimumab Biosimilar.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Effectiveness and Safety of Biosimilars in Pediatric Non-infectious Uveitis: Real-Life Data from the International AIDA Network Uveitis Registry.Ophthalmology and therapy · 2024Article
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.Advances in therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBiologics, 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.
objectiveThe 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 in August 2017 (brand name Imraldi™) and the US Food and Drug Administration in July 2019 (brand name Hadlima™).
methodsA total of 93 SB5 drug product batches manufactured between 2013 and 2022 were analyzed for a series of release parameters to evaluate the consistency in their critical quality attributes including purity, charge variants, and functional activities (TNF-α binding activity and TNF-α neutralizing potency).
resultsThe purity, charge variants, and functional activities of all batches were consistent over time and within the stringent acceptance criteria defined by regulatory agencies to ensure the safety and efficacy of SB5.
conclusionThe data presented in this study provide evidence that the quality of SB5 has remained consistent and tightly controlled even through process changes such as manufacturing site transfers and change in formulation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.