Pharmaceutical & Life Sciences News

House Members Tell Obama to Keep
Data Exclusivity for Biologics at 12 Years

Oct. 20, 2011, 4:00 AM

A group of 51 house members, including Rep. Anna G. Eshoo (D-Calif.), Oct. 14 sent a letter to President Obama to oppose his plan to reduce data exclusivity for brand-name biologic drugs from 12 years to seven years.

Eshoo and the late Sen. Ted Kennedy (D-Mass.) wrote the provision in the health care reform law that created a new Food and Drug Administration pathway for the approval of generic versions of biologic drugs, also called biosimilars. That pathway sets the data exclusivity period—the time during which brand-name biologics are protected from generic competition—at 12 years.

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