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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

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