The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development.
Biosimilars developers and critics of the sector agree on one thing: as it has been implemented in the U.S., the biosimilars pathway hasn’t delivered on its promise to expand access to medicines by creating a competitive market that drives down costs for a broad range of biologics.
Biosimilars that have made it through patent thickets protecting older biologics have been stymied by commercial practices that limit their uptake. There are few if any examples of biosimilar competition causing major price decreases (see “Biosimilars Barriers”).
Frustration with the biosimilars market has driven policy wonks to propose radical solutions, prompting lively debate among policy experts and stakeholders.
Success of the biosimilars sector is important for biopharma companies pursuing innovative products. A robust biosimilars market for off-patent biologics would reduce spending on drugs, freeing financial resources for new medicines and diminish pressures to regulate or control prices of all drugs.
The biotech industry,