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"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.
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.
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.
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
November 13th 2022Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
How Health Policy Can Impact Adoption for Adalimumab Biosimilars
September 25th 2022In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.
