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Scott Gottlieb, MD: Phase 3 Trials and Biosimilars
Scott Gottlieb, MD, former commissioner of the FDA, discusses whether phase 3 trials for biosimilars might eventually be waived in the United States.
Transcript
Well, the process for developing a biosimilar and getting it through the development process is fairly efficient. It’s costly—biosimilar manufacturers will say it will cost anywhere from $100 million to $300 million to develop a biosimilar. A lot of those costs aren’t necessarily the clinical trials, but the cost of actually developing the biosimilar. It’s not a trivial process. The manufacturing cost is substantial. You have to make a big investment in manufacturing when it comes to a biologic.
I think there are ways to continue to make the development process more efficient, in terms of the kind of clinical information that’s required through the regulatory process. I don’t think you’d ever eliminate it. I think there’s always going to be a need to do some level of clinical evaluation and have some component of clinical trials in order to prove the similarity or sameness of the biosimilar to the incumbent biologic, but I think that there are ways to continue to make that process more efficient.
But once again, I don’t think that toggle isn’t going to dramatically change the value proposition and the opportunities when it comes to biosimilars. I think where we’re going to have the most ability to try to move the needle, when it comes to biosimilar adoption, is more on the commercial side.
Physician adoption, physician acceptance, educating doctors about biosimilars, looking at some of the structures in the market that create impediments to biosimilars launching into the market effectively, like the existence of rebates on the incumbent biologic.
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.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
