A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018
Congress has until Friday to finalize a government spending bill. Over the next couple of days it will decide whether to move forward with a number of consequential health care issues, market stabilization and drug pricing chief among them. There is also the possibility of movement around short-term health plans. We cover this and more in this week’s health care preview, which can be found here.
Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing. Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars. While all the attention will be on the former, the latter was more important, especially for participants in the biosimilar space. Continue Reading Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today