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WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.
According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.
The administration originally supported a seven-year exclusivity period while the biosimilars provision still was under debate in Congress, though the final version of the healthcare bill that President Obama signed into law allowed for 12 years. The 12-year period was favored by branded drug and biotech companies, while the generic drug industry wanted an exclusivity period of five years, as pharmaceutical drugs have.
The data exclusivity period is the amount of time the Food and Drug Administration must wait after approving the branded version of a drug before it can accept an application for a generic or biosimilar version.