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.
Viatris Inc.’s Semglee (insulin glargine-yfgn) became the first biosimilar insulin – and the first interchangeable biologic product – in the US with the Food and Drug Administration’s 28 July approval, but lost its labeling on product-specific clinical efficacy and safety data in the process.
The FDA approved Semglee to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults...
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
