The British Society of Gastroenterology (BSG) released new guidance in February 2016 recommending that stable patients be switched to biosimilar infliximab (CT-P13).
Biosimilar infliximab, Remisima/Inflectra (CT-P13), received marketing authorization in June 2013 . The clinical trials used to support this authorization were carried out in rheumatoid arthritis and ankylosing spondylitis. Controlled trials of CT-P13 were not undertaken in Crohn’s disease (CD) or ulcerative colitis (UC). However, evidence for clinical benefit in inflammatory bowel disease has been obtained from several post-marketing studies. The BSG has therefore concluded that 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, and that switching from Remicade to CT-P13 is also safe and effective.
The BSG therefore recommends 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’.
Other recommendations made by the society include:
- Infliximab must be prescribed by brand name, i.e. Remicade, Remsima or Inflectra, and not by International Nonproprietary Name (INN).
- For patients starting infliximab: Remicade, Remsima or Inflectra can be prescribed, taking into account the evidence showing similar clinical effectiveness.
- Automatic substitution 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.
Finnish drug regulator recommends interchangeability of biosimilars
1. GaBI Online – Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: http://gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe