- Authors:
-
Scavone, C; Sessa, M; Clementi, E; Corrao, G; Leone, R; Mugelli, A; Rossi, F; Spina, E; Capuano, A
- Title:
-
Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study
- Year:
-
2018
- Type of item:
-
Articolo in Rivista
- Tipologia ANVUR:
- Articolo su rivista
- Language:
-
Inglese
- Referee:
-
No
- Name of journal:
- Bio Drugs
- ISSN of journal:
- 1173-8804
- N° Volume:
-
32
- Number or Folder:
-
6
- Page numbers:
-
607-617
- Keyword:
-
INFLAMMATORY-BOWEL-DISEASE; PREVENTABILITY ASSESSMENT COMMITTEE; SPONTANEOUS REPORTING SYSTEM; RHEUMATOID-ARTHRITIS; ANTI-TNF; DOUBLE-BLIND; INNOVATOR INFLIXIMAB; BIOLOGIC THERAPIES; INFUSION REACTIONS; NATURAL-HISTORY
- Short description of contents:
- In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity. Therefore, specific contraindications, special warnings and precautions have been introduced in the infliximab Summary of Product Characteristics (SPC).
- Product ID:
-
104673
- Handle IRIS:
-
11562/986671
- Last Modified:
-
November 8, 2022
- Bibliographic citation:
-
Scavone, C; Sessa, M; Clementi, E; Corrao, G; Leone, R; Mugelli, A; Rossi, F; Spina, E; Capuano, A,
Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study
«Bio Drugs»
, vol.
32
, n.
6
,
2018
,
pp. 607-617
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repository istituzionale della Ricerca di Ateneo 
