Anticorps monoclonaux biosimilaires

Beck, Alain; Guillarme, Davy; Fleury-Souverain, Sandrine; Bodier-Montagutelli, Elsa; Respaud, Renaud

doi:10.1051/medsci/2019215

Cited by 1 publication

(1 citation statement)

References 24 publications

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“…The European Medicines Agency (EMA) approved the first biosimilar mAb in 2013 [167]. Currently, near 30 mAb biosimilars have been approved in the European Union (EU) as well as three biosimilars of etanercept [105,168]. These successful candidates have undergone rigorous analytical, nonclinical, and clinical evaluations to demonstrate similarity to the approved biologic [95,98,169].…”

Section: Biosimilars Of Fc-fusion Proteinsmentioning

confidence: 99%

Therapeutic Fc‐fusion proteins: Current analytical strategies

Duivelshof

Murisier

Camperi

et al. 2020

J of Separation Science

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Fc-Fusion proteins represent a successful class of biopharmaceutical products, with already 13 drugs approved in the European Union and United States as well as three biosimilar versions of etanercept. Fc-Fusion products combine tailored pharmacological properties of biological ligands, together with multiple functions of the fragment crystallizable domain of immunoglobulins. There is a great diversity in terms of possible biological ligands, including the extracellular domains of natural receptors, functionally active peptides, recombinant enzymes, and genetically engineered binding constructs acting as cytokine traps. Due to their highly diverse structures, the analytical characterization of Fc-Fusion proteins is far more complex than that of monoclonal antibodies and requires the use and development of additional product-specific methods over conventional generic/platform methods. This can be explained, for example, by the presence of numerous sialic acids, leading to high diversity in terms of iso-

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Section: Biosimilars Of Fc-fusion Proteinsmentioning

confidence: 99%