12:20 PM
Apr 19, 2019
 |  BioCentury  |  Politics, Policy & Law

Thin U.S. biosimilars market fuels proposals to regulate biologics prices

Why academics are calling for replacing biosimilars with price regulation

Frustration over the failure of biosimilars to slash the costs of decades-old biologics has prompted a group of policy analysts to suggest abandoning attempts to copy biologics. Because the sole purpose of biosimilars is to reduce prices, they suggest regulating the prices of biologics that have lost exclusivity rather than spending over $150 million to develop a single biosimilar.

The proposal, published in Health Affairs, is attracting attention, including pushback from former FDA Commissioner Scott Gottlieb and from manufacturers who say it is too early to give up on biosimilars.

The articles are authored by Mark Trusheim, strategic director of the NEWDIGS (NEW Drug Development ParadIGmS) program at the Massachusetts Institute of Technology, Peter Bach, director of Memorial Sloan Kettering Cancer Center’s Center for Health Policy and Outcomes, and two of Bach’s MSKCC colleagues, Preston Atteberry and Jennifer Ohn.

Trusheim and Bach have a track record for influencing federal and state drug pricing policies. They teamed up with Sen. Bill Cassidy (R-La.) to propose the “Netflix model” to improve access to hepatitis C drugs that has been adopted in Louisiana (see “Bach, Trusheim, Sen. Cassidy Outline Scheme for Subscription-Based Purchasing”).

Although the proposal to scrap biosimilars is controversial, there is broad agreement that the U.S. biosimilars market hasn’t come close to meeting the expectations of lawmakers and pundits who expected it to quickly deliver massive savings.

“We believe biosimilars aren’t complete failures, they just are not efficient at achieving the goal we want, which is lowering prices.”

Mark Trusheim, MIT


The question is whether regulatory and legislative reforms can cut development costs and stimulate the creation of a robust market for biosimilars and interchangeable biologics. Trusheim and colleagues argue it’s time to give up.

But Gottlieb, Gillian Woollett, SVP at Avalere Health, as well as biosimilars manufacturers say the biosimilars market can be salvaged.

Thin competition and modest price cuts

“Biosimilar competition is an economically inefficient approach that cannot achieve its full price-reduction goal,” Trusheim,...

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