Insulin Regulation Change Paves Way to Increased Competition, Potential Lower Prices says FDA

Published by Matt Fishman on

A new regulatory process for insulin “is expected to increase patient access, adding more choices and potentially reducing costs of [insulin]”, according to the Food and Drug Administration (FDA).

In accordance with the Biologics Price Competition and Innovation Act of 2009, insulin will now be categorized as a “biological” drug, which will allow for “biosimilar”, interchangeable, versions of insulin to enter the market.

As more insulin biosimilars come to market, the FDA says there will be “incredible potential to reduce health care costs”. Specifically, the FDA reports that historically, “prices are 31 to 39% lower than before the generic competition”.