AHIP Submits Comments to FDA on Naming of Biologics and Biosimilars
posted by AHIP
on May 7, 2019
On May 7, 2019, AHIP submitted a comment letter to the Food and Drug Administration (FDA) on the agency’s draft guidance addressing the nonproprietary naming of biological products. Our comment letter raises serious concerns about the FDA’s draft guidance, including that it could significantly impede the development and approval of less expensive but equally effective biosimilar and interchangeable products.