“If a biosimilar manufacturer with fewer resources wants to compete with an original biologic in more indications, it should focus on therapeutic areas and drug classes that surveyed physicians find most acceptable for extrapolation.”
Many U.S. and European doctors may be wary of using biosimilars to treat patients without clinical data specific to the disease they’re treating, suggests a new analysis by the health care consultancy Decision Resources Group.
That could pose a problem for drugmakers hoping to successfully sell biosimilars medicines once they achieve approvals. If doctors demand more substantial clinical proof that biosimilars are identical to brand name biologics in nearly every respect, drugmakers could be pushed to conduct costly additional trials to clear up the prescribers’ lingering doubts. The threat of such extra costs alone could dissuade some small drugmakers from pursuing biosimilars from the start.
Decision Resources polled 463 physicians from the United States, France, and Germany and found that many doctors are wary of using a biosimilar for an indication for which supporting clinical data are lacking. Attitudes about indication extrapolation—where a biosimilar needs only to show similarity in a late stage study for one indication, and it will be granted approval for other indications for which the branded product is used—vary by country.
French physicians are the most conservative when asked about indication extrapolation when compared to German and U.S. physicians, the company says. It also found that rheumatologists, nephrologists, and gastroenterologists were particularly skeptical of extrapolation, saying that it should not be allowed or “should be done carefully because of minute differences between the biosimilar and the branded product that may be clinically significant.”
It wasn’t surprising to see such caution among the specialists, say Decision Resources analyst Edward Wydysh. He says they “have expressed a moderately conservative approach to biosimilars. If a biosimilar manufacturer with fewer resources wants to compete with an original biologic in more indications, it should focus on therapeutic areas and drug classes that surveyed physicians find most acceptable for extrapolation.”
August 25, 2011
http://www.burrillreport.com/article-doctors_may_need_extra_convincing_on_biosimilars_.html