Today the FDA kicks off 2 days of hearings to begin public debate on regulations that will be needed to implement the follow-on biologics pathway that was autorized in the Price Competition and Innovation Act of 2009 - part of the healthcare reform. The FDA will have members from CBER, CDER and the Office of Compliance present at the hearings.
Other speakers will represent drugmakers, insurers, doctors, investors and policymakers of every shape and size. The three major trade associations PhRMA, BIO and GPhA will also be presenting. According to the announcment of this meeting in the Federal Register - the FDA will be seekign input on the following topics: biosimilarity, interchangeability, patient safety, pharmacovigilance, use of supporting data, definition of a biologic, need for guidance, exclusivity, transition provisions and user fees.
Amgen already issued a press release with its postions regarding on three key criteria: 1. Need for well controlled clinical trials to establish biosimilarity, 2. Identification of manufacturer and lot number for all administered bio drugs, and 3. Set scientific criteria for interchangeability. Presumably, Amgen will argue that these should be as rigorous as possible as it has a portfolio of biologic drugs, and will face challenges to its drugs like EPO as early as 2014.
Posted by Bruce Lehr November 2nd 2010.