Inflammatory bowel disease (IBD) specialists from the European Crohn’s and Colitis Organization (ECCO) issued a new consensus statement that supports switching patients from Remicade, the reference infliximab medication, to a biosimilar infliximab (in Europe, Inflectra/Remsima, Flixabi).1
The new position statement, issued at the ECCO meeting in Vienna, Austria, in October 2016, represents a significant shift from the group’s 2014 position statement, which acknowledged the potential cost-savings from using biosimilars and the increased access to potentially life-changing medicines, but did not advocate switching. Rather, the 2014 statement said there was a need for caution concerning the use of biosimilars and that switching from the originator infliximab biologic to biosimilars was inappropriate.
The new ECCO consensus statement on biosimilars states that based on the regulatory guidance from the European Medicines Agency (EMA) and evidence about the efficacy and safety of biosimilars in IBD patients, ECCO supports switching from the originator biological infliximab to the biosimilar. “When a biosimilar product is registered in the European Union, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summary of Product Characteristics,” the statement declares.
According to the updated consensus statement, biosimilarity is more sensitively characterized by suitable in vitro assays than through performing clinical studies. ECCO supports using clinical studies of equivalence in the medication’s “most sensitive” indication to provide a basis for extrapolating its use for other indications, and states that data for the usage of biosimilars in IBD can be extrapolated from another sensitive indication. However, other professional groups of European gastroenterologist—including pediatric specialists in gastroenterology, hepatology, and nutrition and 2 Spanish medical societies—have issued recommendations expressing concern about extrapolating indications using clinical data from patients with rheumatoid arthritis to patients with IBD.
The consensus statement also points out that adverse events and loss of response due to immunogenicity to a biologic cannot be expected to be overcome with a biosimilar of the same molecule.
The ECCO statement explains that demonstrating the safety of biosimilars requires large observational studies with long-term follow-up in IBD patients. These studies should be supplemented by registries supported by manufacturers, healthcare providers, and patient associations, and traceability should be based on a robust pharmacovigilance system and the manufacturing risk management plan. ECCO’s statement also notes that although switching from the originator to a biosimilar in patients with IBD is acceptable, scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.
Switching from originator to a biosimilar should be performed following an appropriate discussion among physicians, nurses, pharmacists, and patients, and be done according to national recommendations. In particular, ECCO notes that the IBD nurse can play a key role in communicating the importance and equivalence of biosimilar therapy.