Interchangeable Insulin: One Step Forward, Two Steps Back?
US FDA’s update on the process for converting insulin (and a dozen other complex molecules) from “drug” to “biologic” applications is an important milestone, but framing it as progress towards cheaper medicines for diabetics is a bet of stretch.
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Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.
With an eye toward interchangeable insulins, FDA commissioner says existing protein products that will be 'deemed to be licensed' as biologics in March 2020 will not gain any additional exclusivity; coupled with the loss of existing unexpired exclusivity, the decision may spur innovator lawsuits against the agency for an unconstitutional 'taking.'
FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.