Biosimilars Articles
New legislation promised to increase patient access to critical drug products by lower costs. Will it work?
Approvals in 2018 brought the total number of U.S. Food and Drug Administration-licensed biosimilars well into the double digits — and more are in the pipeline.
As biosimilars are introduced into the U.S. market, it remains to be seen whether FDA guidances will ensure their safety and efficacy.
As the approval of biosimilars looms, debate continues over whether they should be substituted for biopharmaceuticals, how to legislate them and how they should be named.
