The US Food and Drug Administration (FDA)’s commissioner, Scott Gottlieb, announced four new guidance documents designed to increase biologic competition.
The most significant change sees a ‘small subset’ of products, including insulin and human growth hormone, switched to a biologics designation as of March 2020.
It is a significant change for manufacturers of insulin; however, Gottlieb stated, “Sponsors have known about this transition for a decade. They’ve had time to prepare.”
Despite having been granted a new biologics pathway, Gottlieb confirmed that these products will not receive any additional exclusivities.
In addition, the new categorisation will allow insulin biosimilar developers to compete in the US market. Gottlieb referred to the entrance of such competition as a “watershed moment for insulin products.”
He continued, “There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible.”
The cost of insulin products has become a flashpoint in the US, with some states, such as Nevada, requiring drug manufacturers to disclose pricing of products and to explain any price increases.
In Gottlieb’s statement, he noted that the annual healthcare spending on insulin runs to $330bn (€291bn) and that the average list price for insulin had increased 15-17% per year from 2012 to 2016.
The FDA commissioner stated that the changes would see competition enter a ‘new era’, adding “these changes and opportunities are long overdue – especially when it comes to insulin.”