Following its move in October to eliminate comparative efficacy studies for biosimilars in development, last week the FDA made further strides to streamline the biosimilar approval process 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.
