Interchangeable Insulins Could Be Left Out Of Diabetes Treatment ‘Ecosystem’
US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.
You may also be interested in...
Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors
US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.
Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder
Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.
Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says
But scientific bridging required for non-US reference products might be more extensive than in other contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.