We Need To Distinguish Biosimilars


Next week, the World Health Organization will meet to make a decision on the best naming approach for biosimilars—products that are similar to complex, large molecule biologics. The root of the issue is whether biosimilars should be given the same name as biologics. Allowing for unique names would make it easier to track side effects appearing in patient records and in regulator reports. “These drugs are not identical [to biologics]and the only way to track side effects is to know which medicine the patient has taken,” says Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry. “There has to be a way to distinguish” biosimilars. Wall Street Journal’s Small Business Blog has the story’s specifics.



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