The Food and Drug Administration and Commissioner Scott Gottlieb have continued their focus on biosimilars; in an interview with CNBC last week Gottlieb said early expectations of savings through biosimilars were “probably not realistic,” but he was still optimistic on the impact biosimilars will have in the U.S. over the coming years.
Broadly, Commissioner Gottlieb said the FDA is working on advancing “a dozen policies” to promote biosimilar development, including the currently marketed biologics. The FDA wants drugmakers to minimize the variables in the manufacturing of branded biotech drugs; hoping this would help bolster the biosimilars markets because less variance should mean faster approval of the medications.
Read Commissioner Gottlieb’s interview with CNBC and the article published by The Center for Biosimliars.