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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Table of Contents: EULAR 2018
Psoriasis and Psoriatic Arthritis
Osteoporosis and Osteoarthritis
Systemic Sclerosis and Systemic Lupus Erythematosus
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