Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health.
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.
Rheumazentrum Ruhrgebiet, Claudiusstr. 45, 44649 Herne, Germany.
Jürgen
J
Braun
Celltrion Inc, Celltrion, 23 Academy-ro, Yeonsu-gu, Incheon 406-840, South Korea. Electronic address: alex.kudrin@celltrion.com.
Alex
A
Kudrin
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D003429:Cross Reactions / Q000276:immunology; D003879:Dermatologic Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care; D011634:Public Health
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D003879:Dermatologic Agents; D005765:Gastrointestinal Agents; D000069285:Infliximab
Biosimilar; Immunogenicity; Infliximab; Interchangeability; Safety; Switching