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Switching to biosimilars in the treatment of rheumatic diseases
- Source :
- Expert Review of Clinical Immunology. 14:557-571
- Publication Year :
- 2018
- Publisher :
- Informa UK Limited, 2018.
-
Abstract
- INTRODUCTION For successful switching of bio-originators to biosimilars, confidence in the switch is an important criterion. To promote confidence, scientific evidence is critical, but still there are insufficient data for the majority of approved biosimilars. Areas covered: Scientific evidence for switching from bio-originator DMARDs to biosimilars is derived from randomized controlled trials (RCTs) for switching, extension studies of RCTs for the approval process, and real-world observational studies. To identify candidate studies, PubMed was searched to collect appropriate studies in all approved biosimilars for the treatment of rheumatic diseases. In addition, abstracts for scientific meetings were reviewed to discover abstracts focused on switching. To date, we have identified 17 extension studies of RCTs, 1 RCT, and 17 real-world observational studies. Most real-world studies have originated from CT-P13 and SB4. Switching was definitively safe and effective in most of studies, but some nocebo effects were observed. Expert commentary: Clear guidelines for switching and data from post-marketing surveillance and registries will be required to confirm existing results on the safety and efficacy of switching from bio-originators to biosimilars. To lessen the nocebo effect against biosimilars, effective educational programs should be provided for all stakeholders, including patients and physicians.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Immunology
Scientific evidence
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Rheumatic Diseases
medicine
Animals
Humans
Immunology and Allergy
Intensive care medicine
Biosimilar Pharmaceuticals
Drug Approval
Expert Testimony
Randomized Controlled Trials as Topic
030203 arthritis & rheumatology
Evidence-Based Medicine
Drug Substitution
business.industry
Biosimilar
Nocebo Effect
030104 developmental biology
Antirheumatic Agents
Observational study
business
Subjects
Details
- ISSN :
- 17448409 and 1744666X
- Volume :
- 14
- Database :
- OpenAIRE
- Journal :
- Expert Review of Clinical Immunology
- Accession number :
- edsair.doi.dedup.....e68769fd0597fb490b7a0dd7e42eee47
- Full Text :
- https://doi.org/10.1080/1744666x.2018.1490178