Adalimumab: a review of the reference product and biosimilars

Azevedo, Valderílio Feijó; Troiano, Ludmila Della Coletta; Galli, Natália Bassalobre; Kleinfelder, Alais Daiane Fadini; Catolino, Nathan M; Martins, Paulo Cesar Urbano

doi:10.2147/bs.s98177

Cited by 14 publications

(7 citation statements)

References 82 publications

(86 reference statements)

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“…From another point of view, despite its long halfli-fe [25], considering the low affinity of adalimumab in mice species, our dosages could be too low to exert a neuroprotective effect. In this respect, future studies with higher dosages and different routes of application (i.e., intraventricular or i.v.)…”

Section: Discussionmentioning

confidence: 98%

Tümör Nekroz Faktörü Alfa Blokeri Adalimumabın Deneysel Beyin Hasarında Etkileri

Günal¹,

Çankaya²,

Tönük

et al. 2019

Acta Medica Alanya

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Amaç: "TNF-alfa inhibitörü Adalimumab'ın, anti-inflamatuvar etkisi nedeniyle inflamasyonla ilişkili nöronal hasarı etkileyebileceği" hipotezine dayanarak adalimumab'ın nöroprotektif rolünü araştırmayı amaçladık. Metotlar: Adalimumab'ın etkilerini araştırmak için soğuk travma modelini kullanarak farelerde beyin hasarı oluşturduk ve krezil viyole boyasıyla hücre sağ-kalım/ölüm oranları ile görüntü analiz sistemi ile hesaplanan infarktüs/ödem hacmini değerlendirdik. Bulgular: Verilerimiz infarkt ve ödem hacminde azalma eğilimi göstermesine rağmen istatistiksel olarak anlamlı değildir. Sonuç: Bildiğimiz kadarıyla çalışmamız adalimumab'ın hasarlı nöronlar üzerindeki nöroprotektif etkisini değerlendiren ilk çalışmadır.

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Section: Discussionmentioning

confidence: 98%

Tümör Nekroz Faktörü Alfa Blokeri Adalimumabın Deneysel Beyin Hasarında Etkileri

Günal¹,

Çankaya²,

Tönük

et al. 2019

Acta Medica Alanya

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“…17e24 Previous reviews on the topic of adalimumab biosimilars, including those by Zhao et al and Azevedo et al, gave insights into the early adalimumab biosimilar landscape, especially with regards to clinical data and pharmacokinetics. 25,26 However, these articles are outdated given how rapidly the field has progressed since the European approval and marketing of adalimumab biosimilars. This review aims to further the knowledge presented in these early articles by addressing the Humira® biosimilar competition approximately two years after the first four biosimilars were released on the European market.…”

Section: Introductionmentioning

confidence: 99%

Overview of Humira® Biosimilars: Current European Landscape and Future Implications

Schwendeman

2021

Journal of Pharmaceutical Sciences

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“…Adalimumab has N‐linked glycosyl moieties at Asn297 in the Fc region of each heavy chain. It is intended for use in the treatment of a range of autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease (Azevedo et al, ). The efficacy and safety of monoclonal antibody therapeutics, including adalimumab, are influenced by the presence of product‐related impurities that can be formed during production, purification, transportation and storage (Alsenaidy, ).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the pattern and kinetics of degradation of adalimumab using a stability‐indicating orthogonal testing protocol

Hassan

Al‐Ghobashy

Abbas

2019

Biomedical Chromatography

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Forced degradation studies are crucial for the evaluation of the stability and biosimilarity. Here, adalimumab was subjected to oxidation, pH, temperature, agitation and repeated freeze-thaw in order to generate all possible degradation products. An orthogonal stability-indicating testing protocol comprising SE-HPLC, RP-HPLC, TapeStation gel electrophoresis, dynamic light scattering (DLS), and functional receptor binding assay was developed and validated. The assay protocol was used for the assessment of the pattern and kinetics of aggregation/degradation of adalimumab. SE-HPLC and DLS were used to show the formation of aggregates/fragments of adalimumab under nondenaturing conditions. TapeStation electrophoresis was performed under denaturing conditions to reveal the nature of aggregates. Results of the receptor binding assay agreed to those of SE-HPLC and DLS which indicated that it can be used as an activity-indicating assay for adalimumab. RP-HPLC demonstrated excellent selectivity for adalimumab in the presence of its oxidized forms. The kineticsof degradation was studied in each case and the results showed that it followed the first-order reaction kinetics. Correlation between the results supported the quality assessment of the tested product in industrial and clinical settings. This orthogonal protocol is a useful tool in stability assessment of monoclonal antibodies and a key criterion for the biosimilarity assessment.

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Adalimumab: a review of the reference product and biosimilars

Cited by 14 publications

References 82 publications

Tümör Nekroz Faktörü Alfa Blokeri Adalimumabın Deneysel Beyin Hasarında Etkileri

Tümör Nekroz Faktörü Alfa Blokeri Adalimumabın Deneysel Beyin Hasarında Etkileri

Overview of Humira® Biosimilars: Current European Landscape and Future Implications

Evaluation of the pattern and kinetics of degradation of adalimumab using a stability‐indicating orthogonal testing protocol

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