New Law Establishes Abbreviated Approval Pathway for Biosimilars in the United States
- Timothy J. Shea
- Sterne, Kessler, Goldstein & Fox P.L.L.C.
On March 23, 2010, President Obama signed into law healthcare reform legislation known as the "Patient Protection and Affordable Care Act." The legislation contains provisions that will establish, for the first time ever, an abbreviated regulatory approval pathway for generic versions of biological medicines (i.e., biosimilars) in the United States.
The progress of the biosimilars legislation in Congress has been closely watched by innovator biopharmaceutical companies, as well as generic drug manufacturers and big pharma. This is the first in a series of reports analyzing the impact of this important new law on the biopharmaceutical industry. In this segment, we explain the most important features of the new biosimilars legislation.