- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
"Not So Different": Is It Time to Give Up on Biosimilars?
It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic. While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.
It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic.
While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.
In a 2-part proposal published on the Health Affairs Blog, a team of authors argued that efforts to induce lower prices through competition via biosimilars will inevitably fail. Instead, they write, prices for innovator biologics should be regulated by the US government after patent expiry.
This week on the podcast, we’re talking with Mark Trusheim, MS, one of the authors of the proposal. He’s a biopharmaceuticals consultant and is also the strategic director of the NEWDIGS program at the Massachusetts Institute of Technology (MIT) Center for Biomedical innovation and a visiting scientist in applied economics at MIT’s Sloan School of Management.
Read more about the proposal from Trusheim and his coauthors.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Biosimilars Gastroenterology Roundup for February 2023—Podcast Edition
March 5th 2023On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.
