FDA Tabling Public Biosimilar Discussions While Digesting Complexities of New Legislation

FDA speakers at recent conferences have been open about their inability to discuss biosimilar issues at this time, while they digest the implications of the recently-passed Patient Protection and Affordable Care Act (PPACA).

At the AAPS National Biotechnology Conference in San Francisco in May, CDER’s Office of Biotechnology Products Laboratory of Biochemistry Chief Emily Shacter explained to the audience that the focus of her talk changed from biosimilars to the role of stability in comparability assessments to accommodate this hiatus.

The PPACA, which was signed into law on March 23, is the health care law in which was embedded a pathway for regulation and approval of biosimilars.  “I have talked about biosimilars for years, but now that we actually have a law it is much more complicated,” Shacter noted.

More from Shacter on FDA’s response to the PPACA is provided for subscribers here.