I believe Congress and the Administration have a moral responsibility and duty to solve the problems before they fail the millions of people who depend on them.
In 2009, this committee passed the Biologics Price Competition and Innovation Act (BPCIA) by a vote of 47 to 11.
I supported the creation of a pathway for biosimilars, and for empowering FDA with the authority and resources to ensure that biosimilars ar...
I was concerned that CMS finalized its Part B payment policy for biosimilars last year combining all biosimilars into one average sales pric...
The Chair thanks the gentlelady. That concludes the questions that we have here. We have follow-up questions. We will submit those to you in...
Biologics are used to treat a number of serious diseases and conditions and have improved the lives of millions of Americans.
FDA approved the first biosimilar in March 2015 and is convening an advisory committee next week to consider a second application.
I urge my colleagues to support both of these amendments and the underlying resolution.
opening statement
The chair thanks the gentleman.
In my mind that would not include issuing guidances, fiats that are expected to be followed, but rather, you go through the normal administr...