Gastroenterologists unlikely to use biosimilar infliximab due to lack of data in IBD

October 1, 2013 9:49 AM

BioTrends Research Group, finds that the majority of surveyed gastroenterologists do not expect to prescribe an infliximab biosimilar, such as Celltrion’s Remsima, in their Crohn’s disease (CD) or ulcerative colitis (UC) patients that has not been clinically tested in inflammatory bowl diseases.

The Biosimilars Advisory Service report entitled Physician Perspectives on Pegylated IFN-alpha and TNF-alpha Inhibitors in Immune and Infectious Disease provides analysis of survey results from over 90 gastroenterologists, as well as more than 90 rheumatologists in the United States and Europe.

The report finds that over 70 percent of surveyed gastroenterologists would not use biosimilar infliximab in CD or UC patients if the clinical trial had only been conducted in rheumatoid arthritis patients. Only a minority of survey respondents believe that indication extrapolation is an overall good idea.

The report also finds that surveyed rheumatologists are similarly cautious about indication extrapolation, but most biosimilars of TNF-alpha inhibitors under development are being studied in rheumatoid arthritis patients. This strategy by biosimilar manufacturers could help to alleviate rheumatologists’ concerns about prescribing these biosimilar TNF-alpha inhibitors, but this study also reveals that rheumatologists would prefer a longer treatment duration and more patients to be included in biosimilar clinical trials compared with their gastroenterology counterparts.

“The concept of indication extrapolation is particularly relevant to prescribers of TNF-alpha inhibitors because of the breadth of indications that these biologics are used in,” said Biosimilars Research Director Kate Keeping. “The first biosimilar TNF-alpha inhibitor that gastroenterologists will have access to, Celltrion/Hospira’s Inflectra (infliximab), has not been clinically tested in CD or UC patients, which will likely limit uptake in these patients, at least until direct clinical evidence is available.”

Source: BioTrends press release

1 Comment

  • Nothing new here. Those seeking to competitively acquire market share (take sales from the ultra-established ref. product) in developed, highly-regulated, affluent countries (major potential biosimilar markets, e.g., US) will simply have to provide documentation that their products work for all of a product’s major indications for which that company markets the product (yes, biosimilars will need to be marketed), particularly if any competing biosimilars (and biobetters) have adequate data for these other indications. In simplistic terms, if a complex product/disease and, particularly if treated by specialists are involved – No Phase III-type safety and efficacy data for an indication = no sales for that indication. This is nothing new, with these issues long discussed (e.g., as I recall at conferences) even well before biosimilar regulatory pathways became reality, e.g., in the EU.

    In affluent highly-regulated countries, e.g., U.S.,, it has long has been obvious, common knowledge, standard practice, etc. that physicians, particularly specialists, will not prescribe products, including reference products for off-label indications and biosimilars, where there is simply no or relatively deficient documentation of efficacy and safety. Besides their professional instincts/training going against this, they simply can’t. Just considering the US, what physician would be foolish enough to prescribe a biosimilar (or a ref. product) for a serious disease where there is simply no or insufficient clinical data for that indication? I think essentially none. The physician would be susceptible to medical malpractice and civil lawsuits, e.g., if a patient sued after experiencing serious adverse events or the patient did not respond (lack of efficacy).

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