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.
Transcript:
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.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.