With Frederick Rein, Scott Warren
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act of 2010 ("PPACA"), Public Law No. 111-148. This massive, groundbreaking piece of legislation contains, or the first time, a statutory pathway for licensure, or approval, of biological products that are biosimilar to, and possibly interchangeable with, earlier biological products (termed "reference products") licensed under the Public Health Service Act.