Reports: FDA says carve-out bills 'undermine trust' in biosimilars

Calif. legislature approved bill earlier this week

NEW YORK — The Food and Drug Administration is concerned about bills in several state legislatures that seek to restrict pharmacists' ability to dispense biosimilars, according to published reports.

Biopharma-Reporter.com quoted an FDA spokeswoman as saying "efforts to undermine trust in these products" were cause for worry and did not serve the interests of patients.

Earlier this week, the lower house of California's General Assembly passed a bill, which had received support from biotech companies like Amgen and Genentech, that would require pharmacists to notify physicians and patients if they swap out a branded biotech drug for a biosimilar. However, the bill contained a sunset clause that means it's only in effect through Jan. 1, 2017, and Gov. Jerry Brown has not indicated whether or not he will sign it.

Similar bills have failed in several states, like Illinois and Florida, while passing in a few others, notably Virginia and North Dakota.

 

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