Introduction: Dr AB Hawthorne, Chair BSG IBD Section Committee
The infliximab biosimilar CT-P13 (Remsima or Inflectra) received marketing authorisation in June 2013.The drug is now widely used in the treatment of inflammatory bowel disease. There is sufficient data from observational studies to show that safety and clinical efficacy of CT-P13 are comparable to the originator drug, with similar immunogenicity.
- Infliximab must be prescribed by brand name (ie Remicade, Remsima or Inflectra) and not by International Non-proprietary Name (INN).
- For patients starting infliximab: Remicade, Remsima or Inflectra can be prescribed, taking into account the evidence showing similar clinical effectiveness. There is evidence that monitoring of patients, including measurement of drug and anti-drug antibody levels, is no different for the biosimilar drugs compared to Remicade. The choice of preparation should take into account the cost of the drug and its administration.
- There is sufficient evidence to recommend that patients who are in a stable clinical response or remission on Remicade therapy can be switched to Remsima or Inflectra at the same dose and dose interval. This should be done after discussion with individual patients, with explanation of the reason for switching (which is usually on the grounds of benefit to the overall service by reduction in costs of the drug and its administration).
- Automatic substitution, (dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber), is not appropriate.
- Pharmacovigilance is essential for any new biological medicine, and patients prescribed Remsima or Inflectra should be followed for safety, in a registry such as the UK National IBD Registry.
This document replaces the previous BSG guidance on Biosimilar drugs - IBD Section Statement on Biosimilar drugs (2014) (View here)