Christine Simmon discussed the Purple Book and how it will affect biosimilar makers and illuminate patent hurdles at the recent FDA/Federal Trade Commission workshop on anticompetitive practices.
Christine Simmon, JD, is the senior vice president of policy & strategic alliances of the Association for Accessible Medicines (AAM) and the executive director of AAM’s Biosimilars Council.
Tell us about the Purple Book and what it will mean for biosimilar makers and patent thickets.
The Purple Book is an FDA version of the current Orange Book. And so what it does is it provides sort of a cheat sheet for biosimilar and other people interested in biosimilar manufacturing and uptake to see what the reference product biologics are and whether or not there are biosimilars currently approved for those products and sort of what we can expect. It's a helpful tool that the FDA has recently made more helpful by rendering it searchable electronically. So, that's a positive development. I think that the Purple Book still suffers from not having mandatory listings of all the patents related to the biologic reference product. That is something that the agency, the FDA, cannot impose by itself, and so legislation would be required for that. And fortunately, there is legislation introduced by Senator Susan Collins [R-ME] to require that the Purple Book include all the patents for a biologic reference product. That would go a long way for biosimilar manufacturers looking to get into those products.