Senators push for 12-year exclusivity model for biosimilars

WASHINGTON As the House and Senate fuse their respective healthcare-reform bills into one, a push has been made to ensure that the final law contains language for knockoffs of biotech drugs.

In a letter to Senate majority leader Harry Reid dated Jan. 13, eight Democratic senators asked that the law preserve a regulatory approval pathway for biosimilars with a 12-year data exclusivity period.

“The pathways for the approval of biosimilars included in both the House and the Senate bills will reduce drug costs for millions of Americans while ensuring continued research and development into innovative biologics which will improve countless lives,” read the letter, signed by Sens. Kay Hagan, North Carolina, Barbara Mikulski, Maryland, Thomas Carper, Delaware, Jack Reed, Rhode Island, John Kerry and Paul Kirk, both of Massachusetts, and Barbara Boxer and Dianne Feinstein of California.

Should the legislation pass with the biosimilars language intact, it will likely put an end to the five-year exclusivity model for which the generic drug industry has long hoped. Under the Hatch-Waxman Act of 1984, which created a regulatory approval pathway for generic drugs, the Food and Drug Administration must wait five years before using a branded drug manufacturer’s clinical trial data to approve a generic, a period known as data exclusivity. The biotechnology industry has maintained that due to the enormous development costs and high probability of failure, it takes developers of biotech drugs a lot longer to break even on new products than it does for pharmaceutical companies. Meanwhile, the generic drug industry says that long exclusivity periods are a ploy used to keep alternatives to expensive biologics off the market for as long as possible.