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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As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.
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contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.
As agency's hearing approaches, a Pink Sheet graphic charts the path for pending and approved applications for insulin, human growth hormone, and certain other protein products when the BPCIA ‘transition provisions’ take effect in March 2020.