USA – FDA changes biological product definition

A month before the long-anticipated transition of applications for certain biological products, including insulin and human growth hormone, to be deemed to be licensed as biologics, the US Food and Drug Administration (FDA) on Thursday issued a final rule amending its definition of “biological product.”

The final rule is one of the last steps in the decade-long transition set in motion by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to deem applications for biologics approved under section 505 the Federal Food, Drug, and Cosmetic Act as being licensed under section 351 of the Public Health Service Act.

Effectively, on 23 March 2020, some 100 products approved under new drug applications (NDAs) will transition to biologics license applications (BLAs). “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” said FDA Commissioner Stephen Hahn…