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:
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Review the data evaluating the safety and effectiveness of switching to CT-P13 accumulated thus far from clinical studies and real-world experience.
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Assess the paradigm shift around the use of biosimilar products in terms of recent national decisions and stakeholder perspectives.
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.