Understand Biosimilars Better Before Seeking Approval, FDA Official Says

Companies applying for approval of a biosimilar drug need to better understand the definitions and key concepts for the compounds, an FDA official told a conference Oct. 27.

“The definition of a biosimilar is two-pronged: it is a biologic product that is highly similar to an already FDA-approved biologic product and it has no meaningful clinical differences from that product,” John K. Jenkins, director of the Food and Drug Administration Center for Drug Evaluation and Research’s Office of New Drugs, told the DIA Biosimilars Conference in Washington.

Biosimilars are defined under the Biologics Price ...