Republicans draw up follow-on biologics bill

WASHINGTON The Democrats’ healthcare-reform bill may have passed in the House Saturday night, but the Republicans drafted a pretty significant piece of healthcare legislation of their own, as well.

Like H.R. 3962, the Affordable Health Care for America Act, H.R. 4083, the Common Sense Healthcare Reform and Affordability Act provides a regulatory pathway that would allow the Food and Drug Administration to approve follow-on biologics. Like the Democrats’ version, it would grant manufacturers of innovator biologics a 12-year period of data exclusivity before the FDA could use its clinical trial data to approve a follow-on version of a drug.

Unlike the Democrats’ bill, however, the Republican bill does not provide a way for follow-on biologics, also called biosimilars, to be substituted for innovator biologics under Medicare and Medicaid billing systems, according to published reports.