Scott Gottlieb, MD, former commissioner of the FDA, discusses how to improve the US biosimilars market.
Transcript
I think continuing to try to make it efficient for biosimilars to get claims of interchangeability will help make the products ultimately more competitive. That process, doing the switching studies to get an interchangeability claim, is fairly efficient, but I think there’s things that you can continue to look at in terms of using real-world evidence and looking at how you structure those switching studies to potentially make it more efficient.
Sometimes those studies are hard to enroll because doctors don't want to enroll patients and patients don't want to enroll in those kinds of studies. So, we do need to continue to look at that, but again, I don’t think that is the biggest impediment if you will, or is going to provide the biggest benefit in terms of trying to foster more competition. I think that the greatest changes that we can make are really going to be on the commercial side.
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.