Tuesday, June 20, 2017

Biosimilars at the 2017 EULAR Annual Meeting in Madrid

Biosimilars are already widely in use in Europe. EMA lists the following products [1]: Amgevita (adalimumab), Benepali (etanercept), Flixabi (infliximab), Inflectra (infliximab), Remsima (infliximab), Solymbic (adalimumab), Truxima (rituximab).
There have been 69 abstracts addressing different aspects of biosimilars. Immunogenicity was of concern. Lots of comparative studies of biosimilars vs. originator have been done. I’ve seen a meta-analysis. I think cost saving is the driving motive to use biosimilars. And making money drives the other side. I won’t comment on all these studies, instead I’ll show you just one study with remarkable results.

B. Glintborg and colleagues presented the following study [2]: “PRESCRIPTION PATTERNS OF BIOLOGICAL DISEASE MODIFYING DRUGS AND BIOSIMILARS IN ANKYLOSING SPONDYLITIS – A COLLABORATION BETWEEN BIOLOGICAL REGISTERS IN THE FIVE NORDIC COUNTRIES”. Conclusions: “The use of bsDMARDs in AS is rapidly increasing. The use of drugs with new modes of action is still low, which illustrates the need for collaboration across countries to provide real life data with sufficient power for new innovative therapies in the future.” The interesting part is the picture. If an infliximab biosimilar is introduced, one would assume that originator infliximab is prescribed less frequently. That happened, but at a slower rate than expected. Also the etanercept biosimilar soared up after introduction. Interestingly this has led to a reduction in prescribing not only of etanercept originator but also of the infliximab biosimilar. But a strange thing happened – the rate of prescriptions for adalimumab, golimumab, and certolizumab decreased rapidly in the wake of the introduction of biosimilars; the drop even accelerated after the launch of the etanercept biosimilar.

Politicians were hoping in the advent of biosimilars, that eventually prices drop. I have my problems with this view as tofacitinib and baricitinib are marketed on the current level of biologics. Maybe I’m wrong and biosimilars will lead to a lower level of costs for needed drugs in rheumatology.

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