Journal
CURRENT RHEUMATOLOGY REPORTS
Volume 19, Issue 6, Pages -Publisher
SPRINGER
DOI: 10.1007/s11926-017-0658-4
Keywords
Biologics; Biosimilars; Switching; Clinical trials; Real world data
Categories
Funding
- Pfizer
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Purpose of Review Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference -> biosimilar switching are limited. This review was carried out to assess the current body of switching data. Recent Findings Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2). Etanercept publications covered SB4 (2) and GP2015 (2). Adalimumab publications covered ABP 501 (2) and SB5 (1). Rituximab publications covered CT-P10 (1). Efficacy and safety data generally showed no differences between patients who switched treatments versus those who did not. No differences were seen pre- and post-switch. Immunogenicity data were presented in 19/37 (51%) studies. Summary Additional data from switching studies of these therapies are still required, as is continuing pharmacovigilance. Switching should remain a case-by-case clinical decision made by the physician and patient on an individual basis supported by scientific evidence.
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