FDA Moves to Facilitate Biosimilar Development
Yesterday, the Food and Drug Administration (FDA) announced long-overdue reforms to the biosimilar approval process that will boost biosimilar development and competition in the United States.
Yesterday, the Food and Drug Administration (FDA) announced long-overdue reforms to the biosimilar approval process that will boost biosimilar development and competition in the United States.
Following the release of the new MGA white paper “The Long-Term Effects of Medicare Price Negotiations on Drug Competition,” Alex Brill spoke with Stanton Mehr at Biosimilars Review & Report.
Alex Brill and Christy Robinson look at the US biosimilars market a decade after the first biosimilar approval.
The Food and Drug Administration (FDA) has approved a record number of biosimilars in 2024, and the year is only half over.
Fourteen years ago, Congress established a regulatory pathway for biosimilars, direct competitors to branded biologic drugs.