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Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health
Braun J, Kudrin A.
This month the article: Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health has been recommended by Prof. Shahzad, in order to have deep insight on multiple aspects of biosimilar infliximab (CT-P13). The article covers the following features:
- Comprehensive and concise review of available data related to switching from reference medicinal products (RMP) to biosimilar infliximab (CT-P13)
- Enlist the randomized clinical trials and observational studies for switchability of CT-P13 in many countries.
- Insight about ongoing registries and post marketing studies for evaluation of CT-P13.
- Spotlight on regularities agencies/countries stance on interchange and substitution of biosimilars.
CT-P13, the biosimilar of infliximab, has been recently approved in the EU, Australia, Canada, Japan and many other countries. Thus, it was the first biosimilar approved in the field of rheumatology, dermatology and gastroenterology. Since there has been debate about the issue of switching from RMP to the biosimilar and some national societies have expressed concerns, this review was written with the following objectives: The review concludes that whilst prudent switching practices should be employed, growing safety experience accumulated thus far with CT-P13 and other biosimilars is favorable and does not raise any specific concerns.
Copyright © 2016 The Authors. Published by Elsevier Ltd. All rights reserved.