FDA Decision on Ipsen’s Acromegaly Drug Upheld, Clears Path for Generics

A panel in Washington, D.C., has upheld the FDA’s decision in a case involving Ipsen’s acromegaly drug, determining that the drug does not meet the definition of a biologic under the Food, Drug, and Cosmetic Act. Ipsen had sought to have its drug classified as a biologic, which would have prevented the approval of generic versions. However, the panel found on Thursday that the drug’s active ingredient does not qualify as a protein, a key criterion for biologic classification. For additional details, you can read the full article on Law360.