UK Guidance on Biosimilars
The National Institute for Health and Care Excellence (NICE) Guidance on the use of Biosimilars57
An adoption resource introducing biosimilar versions of infliximab: Inflectra® and Remsima® has been produced by NICE to help manage the introduction of biosimilar medicines into care pathways in UC57.
The British Society of Gastroenterology (BSG) has also issued guidance following evidence obtained from clinical use of CT-P13* in IBD59.
- “Infliximab must be prescribed by brand name (i.e. 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.”
The British Society for Rheumatology (BSR) position statement on the use of Biosimilars60
- Biologics and biosimilars should be prescribed by brand name.
- Biosimilars should be prescribed with a clear clinical rationale; it is appropriate to include biosimilars as a treatment choice for biologic therapy in new patients, however, switching patients should be on a case-by-case basis and take all available clinical data into account.
- Substitution when dispensing should occur only with the consent of the perscribing clinician.
- Decisions on switching should be made in partnership with the patients.
- Patients should be registered with the BSR Biologic Registers or other appropriate UK register.
European Crohn’s and Colitis Organisation (ECCO) position statement supports the use of biosimilar infliximab in appropriate patients with IBD13.
“Switching from the originator to a biosimilar in patients with IBD is acceptable. Studies of switching can provide valuable evidence for safety and efficacy. Scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients” 13.
“The initial observational data published on efficacy and safety of CT-P13 in IBD, including immunogenicity data, show a profile that completely overlaps with the originator”13.
“Healthcare professionals have the responsibility to ensure that all information is given to the patient to promote shared decision making, confirming informed consent to treatment and evidence-based patient choice”13.
ECCO also encourages the important role of healthcare professionals in patient counselling on biosimilar medicines13.
*CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA®.
UC, Ulcerative colitis; IBD, Inflammatory bowel disease.
PP-IFA-GBR-0299. December 2018