Lawmakers Expand Definition of Biosimilars

A small provision in Congress’ fiscal 2020 budget deal expanded the definition of biosimilars, in a move that could help improve access to insulin and other protein products.

Although most protein products approved as drug products will be forced to face biosimilar and interchangeable competition beginning in March 2020, “chemically synthesized polypeptides” won’t make the transition to regulation as a biosimilar or interchangeable. The current regs serve as a blockade to chemically synthesized copies of protein products, which include every insulin on the market.

Chemically synthesized copies of protein products would be ineligible for the FDA’s abbreviated biosimilar and interchangeable pathways and must submit new drug applications, a process that can cost companies millions of dollars.

The federal budget package amends this exclusion, meaning that the insulin market could see a wave of new competitors.