FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2401471511> ?p ?o ?g. }

• W2401471511 endingPage "8" @default.
• W2401471511 startingPage "7" @default.
• W2401471511 abstract "ting continuous confusion. After successful licensing in several countries around the world, the European licensing authority EMA has recently received the first application for an infliximab biosimilar, which resulted in a positive opinion for appli cation in several inflammatory joint diseases that most likely will be followed by start of marketing in the upcoming year. Facing these developments, the Portuguese Society of Rheumatology has taken the chance (and challenge) to analyze all available data on biosimi lars in rheumatic disease, and has formulated several sta tements that can be regarded pivotal for the European and rheumatologists worldwide with respect to the impact and further use of biosimilars in the daily clinical practice. When analyzing the decisions and statements of the Portuguese colleagues, especially from a country that still has the luxury of a more or less unrestricted access to biologics, several aspects need to be mentioned and commented. To position the patient and his or her medical needs on an individual risk-benefit profile and not solely on an economic basis underlines the value of the human being and the general task of the caring physician. To request clear decision processes and guidelines when applying biologics and biosimilars supports the idea of a clear distinction and positioning of the drug used, even if the biosimilar shows equivalent effects (and side effects such as immunogenicity) in all relevant aspects. Here, it needs to be mentioned that in terms of interchangeability and extrapolation, non-TNF bio simi lars might be a completely different story than TNF biosimilars, as could be seen in the varying outcomes of anti-CD20 and Anti-IL-6 originator antibodies in the past years. The request for monitoring the use and effects of biosimilars in a long-term registry will improve not only the overall knowledge in the field of therapeutic an Although based on very well known cellular and molecu lar targets in chronic inflammatory rheumatic diseases and the proven beneficial effects of the res pective monoclonal therapeutic antibodies since more than a decade, antibody-based biosimilars targeting the same proinflammatory effector molecules and cells appear to become the most intensively discussed drugs amongst rheumatologists, basic scientists, health economists, patients, industry and politicians – to some extent their development even divides the discussants in heavily opposing parties. The background of these turbulences is multifactorial, ranging from i) the interesting scientific question, how “similar“ or “identical“ a therapeutically used human(ized) therapeutic antibody can be if compared to an originator antibody, given the fact that even the batches of the originator drug vary significantly over the years due to variations in the (mostly improved) production processes, to ii) the “natural“ expiration of the patents for the originator biologics, which –owing to their therapeutic successmust stimulate pharmaceutical companies to initiate the development of “bio logic generics“ as performed for chemical drugs on a routine basis, and iii) the painful financial restrictions of the health system of several (European) countries, which demand cheaper drugs to be able to treat more patients according to the state-of-the-art, and iv) the subsequently arising question for the licensing application, whether a successful clinical trial of a biosimilar for a given disease can be extrapolated to other di sease entities without performing further clinical trials, to v) the yet unsolved problem of naming the biosi milar with a unique (international nonproprietary) name vs. “established–mab biosimilar“ without crea -" @default.
• W2401471511 created "2016-06-24" @default.
• W2401471511 creator A5088115834 @default.
• W2401471511 date "2014-05-09" @default.
• W2401471511 modified "2023-10-17" @default.
• W2401471511 title "Comment on: The Portuguese Society of Rheumatology position paper on the use of biosimilars." @default.
• W2401471511 cites W2008613691 @default.
• W2401471511 cites W2024155192 @default.
• W2401471511 cites W2025398922 @default.
• W2401471511 cites W2036508874 @default.
• W2401471511 cites W2080261918 @default.
• W2401471511 cites W2087262031 @default.
• W2401471511 cites W2113182448 @default.
• W2401471511 cites W2120393706 @default.
• W2401471511 cites W2128918690 @default.
• W2401471511 cites W2156899784 @default.
• W2401471511 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/24811455" @default.
• W2401471511 hasPublicationYear "2014" @default.
• W2401471511 type Work @default.
• W2401471511 sameAs 2401471511 @default.
• W2401471511 citedByCount "0" @default.
• W2401471511 crossrefType "journal-article" @default.
• W2401471511 hasAuthorship W2401471511A5088115834 @default.
• W2401471511 hasConcept C126322002 @default.
• W2401471511 hasConcept C138885662 @default.
• W2401471511 hasConcept C142724271 @default.
• W2401471511 hasConcept C197934379 @default.
• W2401471511 hasConcept C199360897 @default.
• W2401471511 hasConcept C204787440 @default.
• W2401471511 hasConcept C2777138892 @default.
• W2401471511 hasConcept C2779134260 @default.
• W2401471511 hasConcept C2779606619 @default.
• W2401471511 hasConcept C35219183 @default.
• W2401471511 hasConcept C41008148 @default.
• W2401471511 hasConcept C41895202 @default.
• W2401471511 hasConcept C512399662 @default.
• W2401471511 hasConcept C57658597 @default.
• W2401471511 hasConcept C59491497 @default.
• W2401471511 hasConcept C71924100 @default.
• W2401471511 hasConceptScore W2401471511C126322002 @default.
• W2401471511 hasConceptScore W2401471511C138885662 @default.
• W2401471511 hasConceptScore W2401471511C142724271 @default.
• W2401471511 hasConceptScore W2401471511C197934379 @default.
• W2401471511 hasConceptScore W2401471511C199360897 @default.
• W2401471511 hasConceptScore W2401471511C204787440 @default.
• W2401471511 hasConceptScore W2401471511C2777138892 @default.
• W2401471511 hasConceptScore W2401471511C2779134260 @default.
• W2401471511 hasConceptScore W2401471511C2779606619 @default.
• W2401471511 hasConceptScore W2401471511C35219183 @default.
• W2401471511 hasConceptScore W2401471511C41008148 @default.
• W2401471511 hasConceptScore W2401471511C41895202 @default.
• W2401471511 hasConceptScore W2401471511C512399662 @default.
• W2401471511 hasConceptScore W2401471511C57658597 @default.
• W2401471511 hasConceptScore W2401471511C59491497 @default.
• W2401471511 hasConceptScore W2401471511C71924100 @default.
• W2401471511 hasIssue "1" @default.
• W2401471511 hasLocation W24014715111 @default.
• W2401471511 hasOpenAccess W2401471511 @default.
• W2401471511 hasPrimaryLocation W24014715111 @default.
• W2401471511 hasRelatedWork W1557591541 @default.
• W2401471511 hasRelatedWork W2097396776 @default.
• W2401471511 hasRelatedWork W2322840961 @default.
• W2401471511 hasRelatedWork W2401471511 @default.
• W2401471511 hasRelatedWork W2574068890 @default.
• W2401471511 hasRelatedWork W2755082435 @default.
• W2401471511 hasRelatedWork W2767797660 @default.
• W2401471511 hasRelatedWork W2899196303 @default.
• W2401471511 hasRelatedWork W3030747463 @default.
• W2401471511 hasRelatedWork W4220658509 @default.
• W2401471511 hasVolume "39" @default.
• W2401471511 isParatext "false" @default.
• W2401471511 isRetracted "false" @default.
• W2401471511 magId "2401471511" @default.
• W2401471511 workType "article" @default.