Matches in SemOpenAlex for { <https://semopenalex.org/work/W3000695215> ?p ?o ?g. }
- W3000695215 endingPage "233" @default.
- W3000695215 startingPage "225" @default.
- W3000695215 abstract "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). SB4 (Benepali®) and SB2 (Flixabi®) were both developed by Samsung Bioepis and are manufactured in Europe by Biogen at their facility in Hillerod, 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. 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. Quality attributes of SB4 and SB2 batches showed little variation and were consistently within the rigorous specifications defined by regulatory agencies." @default.
- W3000695215 created "2020-01-23" @default.
- W3000695215 creator A5003610646 @default.
- W3000695215 creator A5012070285 @default.
- W3000695215 creator A5025666608 @default.
- W3000695215 creator A5038180308 @default.
- W3000695215 creator A5038252616 @default.
- W3000695215 creator A5053789412 @default.
- W3000695215 creator A5058816802 @default.
- W3000695215 creator A5064344364 @default.
- W3000695215 creator A5064958412 @default.
- W3000695215 creator A5070789293 @default.
- W3000695215 creator A5083958659 @default.
- W3000695215 date "2020-01-10" @default.
- W3000695215 modified "2023-10-10" @default.
- W3000695215 title "Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars" @default.
- W3000695215 cites W1954244899 @default.
- W3000695215 cites W1989217623 @default.
- W3000695215 cites W1997106678 @default.
- W3000695215 cites W1998956477 @default.
- W3000695215 cites W2023749561 @default.
- W3000695215 cites W2071095038 @default.
- W3000695215 cites W2080159536 @default.
- W3000695215 cites W2125845245 @default.
- W3000695215 cites W2203977709 @default.
- W3000695215 cites W2236248849 @default.
- W3000695215 cites W2239052723 @default.
- W3000695215 cites W2261829400 @default.
- W3000695215 cites W2281597363 @default.
- W3000695215 cites W2296528535 @default.
- W3000695215 cites W2396604123 @default.
- W3000695215 cites W2409718956 @default.
- W3000695215 cites W2549300825 @default.
- W3000695215 cites W2567453335 @default.
- W3000695215 cites W2607161983 @default.
- W3000695215 cites W2624289061 @default.
- W3000695215 cites W2736727076 @default.
- W3000695215 cites W2745410586 @default.
- W3000695215 cites W2748244654 @default.
- W3000695215 cites W2753749775 @default.
- W3000695215 cites W2764032337 @default.
- W3000695215 cites W2764072601 @default.
- W3000695215 cites W2767179430 @default.
- W3000695215 cites W2778459287 @default.
- W3000695215 cites W2883934894 @default.
- W3000695215 cites W2900652055 @default.
- W3000695215 cites W2901086033 @default.
- W3000695215 cites W2946371282 @default.
- W3000695215 cites W2950815632 @default.
- W3000695215 cites W2969231750 @default.
- W3000695215 cites W651033040 @default.
- W3000695215 doi "https://doi.org/10.1007/s40259-019-00402-0" @default.
- W3000695215 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7113226" @default.
- W3000695215 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31925703" @default.
- W3000695215 hasPublicationYear "2020" @default.
- W3000695215 type Work @default.
- W3000695215 sameAs 3000695215 @default.
- W3000695215 citedByCount "6" @default.
- W3000695215 countsByYear W30006952152021 @default.
- W3000695215 countsByYear W30006952152022 @default.
- W3000695215 crossrefType "journal-article" @default.
- W3000695215 hasAuthorship W3000695215A5003610646 @default.
- W3000695215 hasAuthorship W3000695215A5012070285 @default.
- W3000695215 hasAuthorship W3000695215A5025666608 @default.
- W3000695215 hasAuthorship W3000695215A5038180308 @default.
- W3000695215 hasAuthorship W3000695215A5038252616 @default.
- W3000695215 hasAuthorship W3000695215A5053789412 @default.
- W3000695215 hasAuthorship W3000695215A5058816802 @default.
- W3000695215 hasAuthorship W3000695215A5064344364 @default.
- W3000695215 hasAuthorship W3000695215A5064958412 @default.
- W3000695215 hasAuthorship W3000695215A5070789293 @default.
- W3000695215 hasAuthorship W3000695215A5083958659 @default.
- W3000695215 hasBestOaLocation W30006952151 @default.
- W3000695215 hasConcept C126322002 @default.
- W3000695215 hasConcept C154945302 @default.
- W3000695215 hasConcept C17991360 @default.
- W3000695215 hasConcept C2776436953 @default.
- W3000695215 hasConcept C2777138892 @default.
- W3000695215 hasConcept C2777226972 @default.
- W3000695215 hasConcept C2777575956 @default.
- W3000695215 hasConcept C41008148 @default.
- W3000695215 hasConcept C59491497 @default.
- W3000695215 hasConcept C71924100 @default.
- W3000695215 hasConcept C98274493 @default.
- W3000695215 hasConceptScore W3000695215C126322002 @default.
- W3000695215 hasConceptScore W3000695215C154945302 @default.
- W3000695215 hasConceptScore W3000695215C17991360 @default.
- W3000695215 hasConceptScore W3000695215C2776436953 @default.
- W3000695215 hasConceptScore W3000695215C2777138892 @default.
- W3000695215 hasConceptScore W3000695215C2777226972 @default.
- W3000695215 hasConceptScore W3000695215C2777575956 @default.
- W3000695215 hasConceptScore W3000695215C41008148 @default.
- W3000695215 hasConceptScore W3000695215C59491497 @default.
- W3000695215 hasConceptScore W3000695215C71924100 @default.
- W3000695215 hasConceptScore W3000695215C98274493 @default.
- W3000695215 hasIssue "2" @default.
- W3000695215 hasLocation W30006952151 @default.
- W3000695215 hasLocation W30006952152 @default.