infliximab; reference product; biosimilar; rheumatoid arthritis; PROMs; efficacy; effectiveness; safety; costs; economics; cost-effectiveness; budget impact; legal; social; ethical; organisational
Authors' objectives:
Background: In Switzerland, relatively low biosimilar prescription rates have prompted the interest
of the authorities. A health technology assessment (HTA) was requested to compare the available
evidence of the infliximab reference product and its biosimilar for treating rheumatoid arthritis (RA).
Objective: This HTA examines the efficacy, effectiveness and safety of the infliximab biosimilar
compared to its reference product in RA and presents the health economic impact of a potentially
increased biosimilar utilization in Switzerland. Furthermore, ethical, legal, social and organisational
aspects of treatment initiation with biosimilars or switching to biosimilars are analysed.
Research questions: Is it safe, efficacious and effective 1) to initiate treatment with infliximab biosimilar instead of the infliximab reference product, 2) to switch treatment from the infliximab reference product to infliximab biosimilar and 3) to switch treatment from infliximab biosimilar to the infliximab reference product in patients with RA?
infliximab; reference product; biosimilar; rheumatoid arthritis; PROMs; efficacy; effectiveness; safety; costs; economics; cost-effectiveness; budget impact; legal; social; ethical; organisational
Arthritis, Rheumatoid ; Infliximab ; Antibodies, Monoclonal ; Antirheumatic Agents ; Biological Products
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