Christina Corridon and Vartika Pandya co-wrote this blog post with Scott Kniaz.
March 23, 2020 was a big day for the U.S. insulin market and manufacturers. This day marked the historic completion of the 10-year transition period of certain biologic products, including insulin and human growth hormone, from one regulatory and approval pathway to another. This might sound like nothing more than bureaucratic jargon, but it’s actually very significant, because while insulins have always been biological products, they haven’t always been regulated as such by the FDA. Now that this transition period is over, they will be, increasing competition in a number of different ways. This is all good news for patients, because it’ll drive down prices without, we believe, an impact on innovation.