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Witnesses tell Joint Economic Committee statutory hurdles slow biosimilar competition; panel weighs impact of lower-priced obesity drugs
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Summary
Panelists told the Joint Economic Committee that statutory complexity on biologics and incentives in clinical trials have slowed biosimilar competition; speakers also discussed oral GLP‑1 tablets priced near $149 per month and the potential effects on Medicaid and chronic‑disease spending.
At a Joint Economic Committee hearing, participants argued that statutory and regulatory frameworks are a major reason biosimilar competition has lagged, and they debated how new obesity drugs could alter chronic‑disease spending.
Speaker 2 identified Title VII of the Affordable Care Act—the Biologics Price Competition and Innovation Act of 2009—as having provisions that make it harder to develop and commercialize biosimilars compared with small‑molecule generics. Speaker 2 said that statutory subtleties had left time‑delaying "time bombs in that bill" and asserted that consequence shows up in spending patterns: "is today, 54% of spending in The US on prescription drugs is for biologic drugs that represent less than 4% of prescriptions," Speaker 2 said, adding that 91% of prescriptions are generics.
The panel also discussed market responses such as CivicaRx and cooperative purchasing models. Speaker 3 noted that an oral GLP‑1 tablet expected at about $149 per month could, if scaled, change utilization and Medicaid costs; Speaker 3 also cited an economic estimate that obesity accounts for about $9.1 trillion in additional U.S. health spending over 10 years.
Panelists proposed policy levers including reforming the Biologics Price Competition and Innovation Act implementation, revisiting Stark and anti‑kickback restrictions to enable interoperable technology business models, and rethinking clinical‑trial incentives to encourage innovation for common chronic diseases. No formal legislative action occurred during the hearing.
The hearing closed with plans for further review by staff and members.
