FDA Gives Biosimilars Update
Published by Angie Drakulich on February 3, 2012 02:39 pm under Biotech, Regulation, Uncategorized
Rachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary.
In terms of background, the BPCI Act was passed in March 2010 as part of Affordable Care Act, and it creates an abbreviated licensure pathway for biological products shown to be biosimilar or interchangeable with an FDA-licensed reference product (section 351k of Public Health Service Act). FDA is eager to have an informational discussion on this topic because with the new pathway program, the agency is “essentially launching an entirely new regulatory paradigm” and public needs to understand this, said Sherman....