FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2023488801> ?p ?o ?g. }

• W2023488801 endingPage "23" @default.
• W2023488801 startingPage "23" @default.
• W2023488801 abstract "Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years&#39; experience of the European Union regulatory pathway Paul D Chamberlain NDA Advisory Board, NDA Advisory Services Ltd, Surrey, UK Abstract: Clinical evaluation of comparative immunogenicity represents an important component of the European Union regulatory review process for candidate biosimilar products. The clinical evaluation is part of a multidisciplinary review that cross-refers to product quality attributes as well as preclinical and ongoing risk management considerations. Results from the monitoring of anti-drug antibody formation in relevant populations treated for an adequate period of time are interpreted in relation to clinically relevant endpoints, including pharmacokinetics, pharmacodynamics, efficacy, and safety parameters. The European Union regulatory standard for designation of biosimilarity requires a suitable weight of evidence, determined on a product-specific basis, to demonstrate that the immunogenicity associated with the biosimilar product does not lead to a higher negative impact on clinically relevant outcomes compared with the reference product. The experience gained during the 10-year period following the implementation of the European Union biosimilars pathway indicates that a suitably cautious approach was applied, insofar as no immunogenicity-related issues have emerged for the approved applications of the different biosimilar products. In some cases, product quality-related issues were identified in the preauthorization setting as being potentially relevant for heightened risk of immunogenicity and were duly taken into account for the biosimilarity decision. Some unresolved issues remain, most notably concerning the limitation of noninterventional post-marketing surveillance measures to monitor the potential for changes in immunogenicity over the longer term, eg, following introduction of changes in manufacture, formulation, or primary product container. Lack of standardization of bioanalytical methods precludes comparison of anti-drug antibody formation for different products that are evaluated in noncomparative clinical studies, and correlation with relevant clinical parameters is also lacking. Keywords: immunogenicity, biosimilar, regulatory, clinical, preclinical, bioanalytical" @default.
• W2023488801 created "2016-06-24" @default.
• W2023488801 creator A5054724032 @default.
• W2023488801 date "2014-06-01" @default.
• W2023488801 modified "2023-10-05" @default.
• W2023488801 title "Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years&#39; experience of the European Union regulatory pathway" @default.
• W2023488801 cites W1821162804 @default.
• W2023488801 cites W1950293547 @default.
• W2023488801 cites W1966025583 @default.
• W2023488801 cites W1985686555 @default.
• W2023488801 cites W1997062903 @default.
• W2023488801 cites W1998432185 @default.
• W2023488801 cites W2001607896 @default.
• W2023488801 cites W2004636947 @default.
• W2023488801 cites W2017759102 @default.
• W2023488801 cites W2024155192 @default.
• W2023488801 cites W2039442988 @default.
• W2023488801 cites W2041723098 @default.
• W2023488801 cites W2042920536 @default.
• W2023488801 cites W2043261411 @default.
• W2023488801 cites W2048087821 @default.
• W2023488801 cites W2050818535 @default.
• W2023488801 cites W2067197313 @default.
• W2023488801 cites W2070848328 @default.
• W2023488801 cites W2078172351 @default.
• W2023488801 cites W2078662965 @default.
• W2023488801 cites W2081561057 @default.
• W2023488801 cites W2093690817 @default.
• W2023488801 cites W2098398245 @default.
• W2023488801 cites W2113126462 @default.
• W2023488801 cites W2122468868 @default.
• W2023488801 cites W2123556713 @default.
• W2023488801 cites W2125889316 @default.
• W2023488801 cites W2128666733 @default.
• W2023488801 cites W2133832905 @default.
• W2023488801 cites W2138706730 @default.
• W2023488801 cites W2140035322 @default.
• W2023488801 cites W2144099510 @default.
• W2023488801 cites W2145746917 @default.
• W2023488801 cites W2159029707 @default.
• W2023488801 cites W280478335 @default.
• W2023488801 doi "https://doi.org/10.2147/bs.s50012" @default.
• W2023488801 hasPublicationYear "2014" @default.
• W2023488801 type Work @default.
• W2023488801 sameAs 2023488801 @default.
• W2023488801 citedByCount "13" @default.
• W2023488801 countsByYear W20234888012015 @default.
• W2023488801 countsByYear W20234888012016 @default.
• W2023488801 countsByYear W20234888012017 @default.
• W2023488801 countsByYear W20234888012018 @default.
• W2023488801 countsByYear W20234888012019 @default.
• W2023488801 countsByYear W20234888012020 @default.
• W2023488801 crossrefType "journal-article" @default.
• W2023488801 hasAuthorship W2023488801A5054724032 @default.
• W2023488801 hasBestOaLocation W20234888011 @default.
• W2023488801 hasConcept C112930515 @default.
• W2023488801 hasConcept C126322002 @default.
• W2023488801 hasConcept C144133560 @default.
• W2023488801 hasConcept C149091818 @default.
• W2023488801 hasConcept C155202549 @default.
• W2023488801 hasConcept C17744445 @default.
• W2023488801 hasConcept C186846655 @default.
• W2023488801 hasConcept C199360897 @default.
• W2023488801 hasConcept C199539241 @default.
• W2023488801 hasConcept C203014093 @default.
• W2023488801 hasConcept C22467394 @default.
• W2023488801 hasConcept C2524010 @default.
• W2023488801 hasConcept C2777904410 @default.
• W2023488801 hasConcept C2780868878 @default.
• W2023488801 hasConcept C2910001868 @default.
• W2023488801 hasConcept C33923547 @default.
• W2023488801 hasConcept C37945671 @default.
• W2023488801 hasConcept C41008148 @default.
• W2023488801 hasConcept C59491497 @default.
• W2023488801 hasConcept C71924100 @default.
• W2023488801 hasConcept C8891405 @default.
• W2023488801 hasConcept C90673727 @default.
• W2023488801 hasConceptScore W2023488801C112930515 @default.
• W2023488801 hasConceptScore W2023488801C126322002 @default.
• W2023488801 hasConceptScore W2023488801C144133560 @default.
• W2023488801 hasConceptScore W2023488801C149091818 @default.
• W2023488801 hasConceptScore W2023488801C155202549 @default.
• W2023488801 hasConceptScore W2023488801C17744445 @default.
• W2023488801 hasConceptScore W2023488801C186846655 @default.
• W2023488801 hasConceptScore W2023488801C199360897 @default.
• W2023488801 hasConceptScore W2023488801C199539241 @default.
• W2023488801 hasConceptScore W2023488801C203014093 @default.
• W2023488801 hasConceptScore W2023488801C22467394 @default.
• W2023488801 hasConceptScore W2023488801C2524010 @default.
• W2023488801 hasConceptScore W2023488801C2777904410 @default.
• W2023488801 hasConceptScore W2023488801C2780868878 @default.
• W2023488801 hasConceptScore W2023488801C2910001868 @default.
• W2023488801 hasConceptScore W2023488801C33923547 @default.
• W2023488801 hasConceptScore W2023488801C37945671 @default.
• W2023488801 hasConceptScore W2023488801C41008148 @default.
• W2023488801 hasConceptScore W2023488801C59491497 @default.
• W2023488801 hasConceptScore W2023488801C71924100 @default.
• W2023488801 hasConceptScore W2023488801C8891405 @default.

• next