Pubblicazioni

Autori:

Scavone, C; Sessa, M; Clementi, E; Corrao, G; Leone, R; Mugelli, A; Rossi, F; Spina, E; Capuano, A

Titolo:

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study

Anno:

2018

Tipologia prodotto:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Lingua:

Inglese

Referee:

No

Nome rivista:

Bio Drugs

ISSN Rivista:

1173-8804

N° Volume:

32

Numero o Fascicolo:

6

Intervallo pagine:

607-617

Parole chiave:

INFLAMMATORY-BOWEL-DISEASE; PREVENTABILITY ASSESSMENT COMMITTEE; SPONTANEOUS REPORTING SYSTEM; RHEUMATOID-ARTHRITIS; ANTI-TNF; DOUBLE-BLIND; INNOVATOR INFLIXIMAB; BIOLOGIC THERAPIES; INFUSION REACTIONS; NATURAL-HISTORY

Breve descrizione dei contenuti:

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).

Id prodotto:

104673

Handle IRIS:

11562/986671

ultima modifica:

8 novembre 2022

Citazione bibliografica:

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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