New Legislation Introduced On Biogenerics

A new bill introduced Thursday in the US House of Representatives could, if passed, create a pathway for generic versions of complex medications, called biologics, to be approved by the US Food and Drug Administration. Bills for such a pathway have been introduced before, but none have yet passed.

Teva Pharmaceuticals, a leading generics manufacture “applauded” the bill, but the Biotechnology Industry Organization, which represents innovator drug companies as well as generics, said it was “full of potholes.”

The “Promoting Innovation and Access to Life-Saving Medicine Act,” was introduced by Reps. Henry Waxman (D, California), Frank Pallone (D, New Jersey), Nathan Deal (R, Georgia), and Jo Ann Emerson (R, Missouri).