Last July 2015, NICE published HTTA329 as a reference for select NHS organizations in the UK that are currently planning to join the market with their own biosimilar products for the treatment of a wide range of diseases, including Inflammatory Bowel Disease. The MSD, which operates in over 140 countries and to provide prescription medicines, vaccines, biologic therapies, and animal health products, responded with this statement:
“The evidence base for switching stable Remicade® patients to biosimilar infliximab remains limited and inconclusive – data from small scale local observational studies with relatively small numbers of patients and short term duration have been shared at international congresses.
MSD advocates the need for larger scale, more robust studies (i.e. randomized, double-blinded and properly powered) to provide more evidence on efficacy, safety and immunogenicity outcomes of switching stable Remicade patients.
Our position is consistent with that of scientific societies such as EULAR, ECCO, ESPGHAN and ACR, which state that the principal driver for decisions is sound scientific evidence and that patients responding to their therapy well should be allowed to continue their current biologic treatment.”
Infliximab is a chimeric monoclonal antibody that works against tumour necrosis factor alpha (TNF-α) used to treat autoimmune diseases. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
While HTTA329 was published as a resource to concerned NHS organizations, it does not in any way mandate any guidelines in the United Kingdom. The company also recognized the following points from the NICE publication:
- The need for brand name prescribing of biologics
- Informed patient consent for switching medicines, but with the decision remaining with the prescribing clinician
- Biosimilars’ originators are not interchangeable
- Patient outcomes should be monitored and recorded.
However, MSD pointed out that HTTA329 is not in agreement with where the professional and patient groups in the UK, Europe, and USA stand in the belief that patients with a stable condition should not be switched to using biosimilars based on treatment cost alone.
While some concerned UK centers have a modified approach to prescribing infliximab in new and existing patients, they do not reflect the foreseen consequences of a large-scale switch of patients to biosimilars, which scientists believe may affect patient outcomes.