New U.S. Law Establishes Long Awaited Abbreviated Approval Pathway for Biosimilars
- Timothy J. Shea, Jr. and Tracy L. Muller
On March 21, 2010, the U.S. Congress passed landmark healthcare reform legislation, known as the "Patient Protection and Affordable Care Act," that will dramatically reshape the biopharmaceutical industry. This historic piece of legislation contains provisions that establish, for the first time ever, an abbreviated regulatory approval pathway for generic versions of biological medicines (i.e., biosimilars) in the United States. Click here to read the full article.