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.
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.
MGA’s Alex Brill was interviewed by Mari Serebvrov for a new piece in BioWorld to discuss the latest with the adalimumab market as new competition is expected as early as July 1.