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Organon's Jim Carey Shares Thoughts on Biosimilar Legislation, Emerging Adalimumab Products
Jim Carey, head of US policy and government relations at Organon, a spinoff company from Merck, breaks down strategies to push forward biosimilar legislation, the anticipation for adalimumab biosimilars, and more in this multi-part interview.
EP: 1.Organon's Jim Carey Examines Actions FDA Could Take to Reduce Biosimilar Education Gaps
EP: 2.Organon's Jim Carey Outlines the Company's Biosimilars Approach, Hopes for Future
EP: 3.Organon's Jim Carey Says Education is Needed to Push Biosimilar Legislation Forward
EP: 4.Organon's Jim Carey Highlights Why More Incentives for Biosimilar Use Are Needed
EP: 5.Jim Carey Discusses How Organon Is Working to Push the BIOSIMS Act Forward
EP: 6.Organon's Jim Carey Expresses Need for Better Policies Clarifying Interchangeability
EP: 7.Organon's Jim Carey Previews the Launch of Adalimumab Biosimilars, Predicts CMS Changes
EP: 8.Organon's Jim Carey Predicts Device Could Influence Which Adalimumab Biosimilars Succeed
Transcript
How has education around generics and biosimilars evolved over the years and where is it still lacking?
Carey: I think generics are pretty well understood at this point having been available on the market about 35 years. They've grown to about 95% of all US prescriptions. And I think it's pretty well understood that those are essentially the same product as the originator product.
That's not the case with biosimilars. Biosimilars, unfortunately, are still subject to a tremendous amount of misinformation and disparagement, and cause a lot of confusion. It's I always use the term "FUD": fear, uncertainty, and doubt, which is being sown out there and really has a lot of providers who are confused. The FDA has produced a tremendous amount of of educational material and, unfortunately, it hasn't been spread widely enough to really satisfy some concerns that some providers might have.
I would also say that in right at the beginning of the the [COVID-19] pandemic in spring of 2020, the FDA and FTC [Federal Trade Commission] put out a guidance on promotion of biologics and biosimilars, and I think there probably ought to be a little bit more enforcement of that focused on some of this misinformation that's out there.
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