Deborah L. Lu, Ph.D., Shareholder and member of the firm's Intellectual Property practice group, was quoted in the Bloomberg BNA Life Sciences Law & Industry Report article, "High Court Upholds Health Reform Law, Biosimilars Pathway Remains Operative."
This article addresses the recent Supreme Court decision to uphold health system reforms in the Patient Protection and Affordable Care Act (PPAC). It also discusses how PPAC provisions affecting life sciences companies, such as the abbreviated pathway for biosimilars, will move forward. Dr. Lu comments on the lingering uncertainty over FDA guidelines. "‘There still remains, however, some uncertainty about biosimilars as a result of the Food and Drug Administration guidelines that came out Feb. 12, 2012, and that created more questions than they have answers."
To read the entire article, please click on the link below.