FDA keeps up the pace on insulin and biologic competition

Changes that will open up insulins and other biologics to more competition in the US market are now just a month away.

On March 23, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act, including applications for insulins and other biological products, will be deemed to be a license for the product under the Public Health Service Act.

"This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin"For the first time, this will enable the submission of applications for therapies that are proposed as biosimilar to, or interchangeable with, the transitioned products.