BioCentury
ARTICLE | Regulation

Lackluster U.S. biosimilars market sparks radical recommendations

The U.S. biosimilars market isn’t living up to its promise, prompting calls for rethinking the regulatory paradigm

September 6, 2019 7:20 PM UTC

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. ...