Home > Rheumatology > EULAR 2018 > Rheumatoid Arthritis > Switching to Biosimilar bDMARDs Is Safe and Efficacious

Switching to Biosimilar bDMARDs Is Safe and Efficacious

Presented By
Prof. Kvien, University of Oslo and Diakonhjemmet Hospital, Norway
Conference
EULAR 2018
Trial
Phase 4, NOR-SWITCH

The use of biosimilars has truly taken off in the past few years and is expected to increase further. Results have shown that switching to biosimilar CT-P13 is not inferior to continued treatment with originator infliximab. These findings add to the increasing real-world evidence that switching from originator to biosimilar biological disease-modifying antirheumatic drugs (bDMARDs) is safe and efficacious.

Regulatory agencies in Europe and the United States have set up strict guidelines for the approval of biosimilars, which include extensive pre-clinical examinations. These guidelines also permit abbreviated clinical development paths for biosimilars than for an originator product. In general, biosimilars will be considered on the same level as originator products when treatments are started or changed for medical reasons by most rheumatologists. On the contrary, replacing an originator product by a biosimilar is carried out on non-medical grounds for (substantial) cost-s...



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