Biosimilar medicines in inflammatory bowel disease

What are the consequences?

For patients starting biological treatment for the first time, the least costly alternative will now be infusion with Remsima. The financial savings available with Remsima will make it likely that this will be the drug of choice. In that case a certain level of uncertainty must be accepted, since the effect of Remsima in Crohn’s disease and ulcerative colitis has not been documented in randomised studies. The patient should therefore also be included in the decision regarding choice of treatment and route of administration. Finally, the issue of treatment capacity at the hospital’s outpatient infusion clinic may have a decisive impact on the choice.

From a medical standpoint, a much more problematic question is whether those already receiving treatment with Remicade with good results should switch to a much less costly biosimilar alternative. We would now strongly advise against this, as biosimilar is not synonymous with bioidentical and because, as of today, the consequences of such a change are uncertain. Loss of primary efficacy and antibody development with severe infusion reactions as possible adverse effects are not inconceivable. Because of a lack of documented efficacy and safety when switching between biosimilar medicines, an additional allocation of NOK 20 million has been set aside in the state budget for a clinical study in the fields of rheumatology, gastroenterology and dermatology. In our opinion, the natural consequence of this is that no patients with inflammatory bowel disease should switch to a biosimilar medicine before they have received an offer to participate in the planned treatment-switching study. Switching to a biosimilar medicine when Remicade has lost its efficacy, or adverse effects have occurred, is also highly problematic, since the same efficacy and adverse effect profile may be expected after the switch. On the other hand, switching to Remsima due to lack of efficacy or adverse effects with Humira or Simponi is considered to be a viable alternative, where until now we have tried Remicade.

In summary, we believe that there is an absence of good documentation on the use of biosimilar medicines for ulcerative colitis and Crohn’s disease. This creates uncertainty for decision-makers in national and international health policy and in medical communities. Unresolved questions about efficacy and safety are of great concern to the medical community, and new studies are needed to clarify this. Norwegian authorities have allocated tens of millions of kroner for this purpose, and it would have been advantageous to have such a clarification before the Norwegian Drug Procurement Cooperation announced its recommendations.

The decision as to when biosimilar medicines should be chosen now lies with the individual specialist and hospital administration, with the responsibility that this entails. In the absence of a common decision-making arena regarding the medical stance on switching, registers that can follow up patients, and initiation of a study that requires that patients on established treatment switch under close monitoring, it is our opinion that we specialists should lean towards a sceptical, conservative approach.