US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says
Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.
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Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.
The agency aims to treat ANDAs approved prior to enactment of the Hatch-Waxman amendments, dubbed PANDAs, as 505(b) NDAs. The goal is to make it easier to designate products as reference listed drugs, but experts say it effectively turns ANDA holders into NDA holders, which could have implications for label changes, patent listings, and product liability litigation.
Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.