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.
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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.
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.
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contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.