Doctors reluctant to prescribe biosimilars for extrapolated indications

September 27, 2012 7:49 AM

BioTrends Research Group, one of the research and advisory firms for specialized biopharmaceutical issues, finds that surveyed gastroenterologists and rheumatologists in the United States and Europe have a low or medium-low likelihood of prescribing a biosimilar for an indication in which it has not been clinically tested.

According to Biosimilars Advisory Service: Physician Perspectives on Biologics in Immunology & Infectious Disease, a similar proportion of surveyed rheumatologists and gastroenterologists, 49 percent and 47 percent, respectively, say that indication extrapolation should be performed carefully because some patients might be more sensitive to minute differences between the brand and the biosimilar.

Survey findings suggest that in order for gastroenterologists and rheumatologists to feel comfortable prescribing a biosimilar, a randomized, Phase III trial comparing the biosimilar to its reference brand would be required in all indications. This differs from regulatory guidance in the United States, Europe and Japan which states that indication extrapolation is permitted, as long as it is scientifically justified by the applicant.

“Surveyed gastroenterologists and rheumatologists are hesitant to adopt biosimilars unless these agents demonstrate robust clinical data, so incentives, like cost reduction, will be important to facilitate uptake,” said Biosimilars Advisory Service Director, Andrew Merron, Ph.D. “Despite the moderate uptake of biosimilars that we expect from these specialists, the sheer size of this market means that biosimilars for immune diseases will be the most lucrative class of biosimilars by 2021.”

The Physician Perspectives on Biologics in Immunology & Infectious Disease module of the Biosimilars Advisory Service offers extensive primary research with US, French and German gastroenterologists and rheumatologists to highlight the key expectations that will drive or constrain biosimilar adoption. Insights from surveyed gastroenterologists and rheumatologists provide a sound basis for annualized, brand-specific biosimilar sales forecasts for the TNF-alpha inhibitors, other major biologics used in immune diseases and pegylated interferon alpha products, which are all included in the module. Sales forecasts are provided through 2021 across the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, the United Kingdom and Japan).

 

Source: BioTrends press release

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